EU Medical Device Directive - MDD 93/42/EC - ROCH...devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is

EU Medical Device

Directive - MDD

93/42/EC COUNCIL DIRECTIVE 93/42/EEC of 14 June

1993 concerning medical devices and as

amended by Directive 2007/47/EC of the

European Parliament and of the Council of

5 September 2007

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►B COUNCIL DIRECTIVE 93/42/EEC

of 14 June 1993

concerning medical devices

(OJ L 169, 12.7.1993, p. 1)

Amended by:

Official Journal

No page date

►M1 Directive 98/79/EC of the European Parliament and of the Council of27 October 1998

L 331 1 7.12.1998

►M2 Directive 2000/70/EC of the European Parliament and of the Council of16 November 2000

L 313 22 13.12.2000

►M3 Directive 2001/104/EC of the European Parliament and of the Councilof 7 December 2001

L 6 50 10.1.2002

►M4 Regulation (EC) No 1882/2003 of the European Parliament and of theCouncil of 29 September 2003

L 284 1 31.10.2003

►M5 Directive 2007/47/EC of the European Parliament and of the Council of5 September 2007

L 247 21 21.9.2007

1993L0042 — EN — 11.10.2007— 005.001— 1

▼B

COUNCIL DIRECTIVE 93/42/EEC

of 14 June 1993

concerning medical devices

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European EconomicCommunity, and in particular Article 100a thereof,

Having regard to the proposal from the Commission (1),

In cooperation with the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas measures should be adopted in the context of the internalmarket; whereas the internal market is an area without internalfrontiers in which the free movement of goods, persons, services andcapital is ensured;

Whereas the content and scope of the laws, regulations and adminis-trative provisions in force in the Member States with regard to thesafety, health protection and performance characteristics of medicaldevices are different; whereas the certification and inspection proceduresfor such devices differ from one Member State to another; whereas suchdisparities constitute barriers to trade within the Community;

Whereas the national provisions for the safety and health protection ofpatients, users and, where appropriate, other persons, with regard to theuse of medical devices should be harmonized in order to guarantee thefree movement of such devices within the internal market;

Whereas the harmonized provisions must be distinguished from themeasures adopted by the Member States to manage the funding ofpublic health and sickness insurance schemes relating directly orindirectly to such devices; whereas, therefore, the provisions do notaffect the ability of the Member States to implement the abovemen-tioned measures provided Community law is complied with;

Whereas medical devices should provide patients, users and third partieswith a high level of protection and attain the performance levelsattributed to them by the manufacturer; whereas, therefore, the main-tenance or improvement of the level of protection attained in theMember States is one of the essential objectives of this Directive;

Whereas certain medical devices are intended to administer medicinalproducts within the meaning of Council Directive 65/65/EEC of 26January 1965 on the approximation of provisions laid down by law,regulation or administrative action relating to proprietary medicinalproducts (4); whereas, in such cases, the placing on the market of themedical device as a general rule is governed by the present Directiveand the placing on the market of the medicinal product is governed byDirective 65/65/EEC; whereas if, however, such a device is placed onthe market in such a way that the device and the medicinal product forma single integral unit which is intended exclusively for use in the givencombination and which is not reusable, that single-unit product shall begoverned by Directive 65/65/EEC; whereas a distinction must be drawnbetween the abovementioned devices and medical devices incorporating,inter alia, substances which, if used separately, may be considered to bea medicinal substance within the meaning of Directive 65/65/EEC;whereas in such cases, if the substances incorporated in the medicaldevices are liable to act upon the body with action ancillary to thatof the device, the placing of the devices on the market is governed by

1993L0042 — EN — 11.10.2007— 005.001— 2

(1) OJ No C 237, 12.9.1991 and OJ No C 251, 28.9.1992, p. 40.(2) OJ No C 150, 31.5.1993 and OJ No C 176, 28.6.1993.(3) OJ No C 79, 30.3.1992, p. 1.(4) OJ No 22, 9.6.1965, p. 369/65. Directive as last amended by Directive 92/27/

EEC (OJ No L 113, 30.4.1992, p. 8).

▼B

this Directive; whereas, in this context, the safety, quality andusefulness of the substances must be verified by analogy with theappropriate methods specified in Council Directive 75/318/EEC of 20May 1975 on the approximation of the laws of the Member Statesrelating to analytical, pharmaco-toxicological and clinical standardsand protocols in respect of the testing of proprietary medicinalproducts (1);

Whereas the essential requirements and other requirements set out in theAnnexes to this Directive, including any reference to ‘minimizing’ or‘reducing’ risk must be interpreted and applied in such a way as to takeaccount of technology and practice existing at the time of design and oftechnical and economical considerations compatible with a high level ofprotection of health and safety;

Whereas, in accordance with the principles set out in the Council reso-lution of 7 May 1985 concerning a new approach to technical harmo-nization and standardization (2), rules regarding the design and manu-facture of medical devices must be confined to the provisions requiredto meet the essential requirements; whereas, because they are essential,such requirements should replace the corresponding national provisions;whereas the essential requirements should be applied with discretion totake account of the technological level existing at the time of design andof technical and economic considerations compatible with a high levelof protection of health and safety;

Whereas Council Directive 90/385/EEC of 20 June 1990 on the approx-imation of the laws of the Member States relating to active implantablemedical devices (3) is the first case of application of the new approachto the field of medical devices; whereas in the interest of uniformCommunity rules applicable to all medical devices, this Directive isbased largely on the provisions of Directive 90/385/EEC; whereas forthe same reasons Directive 90/385/EEC must be amended to insert thegeneral provisions laid down in this Directive;

Whereas the electromagnetic compatibility aspects form an integral partof the safety of medical devices; whereas this Directive should containspecific rules on this subject with regard to Council Directive 89/336/EEC of 3 May 1989 on the approximation of the laws of the MemberStates relating to electromagnetic compatibility (4);

Whereas this Directive should include requirements regarding the designand manufacture of devices emitting ionizing radiation; whereas thisDirective does not affect the authorization required by CouncilDirective 80/836/Euratom of 15 July 1980 amending the Directiveslaying down the basic safety standards for the health protection of thegeneral public and workers against the dangers of ionizing radiation (5),nor application of Council Directive 84/466/Euratom of 3 September1984 laying down basic measures for the radiation protection of personsundergoing medical examination or treatment (6); whereas CouncilDirective 89/391/EEC of 12 June 1989 on the introduction ofmeasures to encourage improvements in the safety and health ofworkers at work (7) and the specific directives on the same subjectshould continue to apply;

Whereas, in order to demonstrate conformity with the essentialrequirements and to enable conformity to be verified, it is desirable tohave harmonized European standards to protect against the risks asso-ciated with the design, manufacture and packaging of medical devices;

1993L0042 — EN — 11.10.2007— 005.001— 3

(1) OJ No L 147, 9.6.1975, p. 1. Directive as last amended by Directive 91/507/EEC (OJ No L 270, 26.9.1991, p. 32).

(2) OJ No C 136, 4.6.1985, p. 1.(3) OJ No L 189, 20.7.1990, p. 17.(4) OJ No L 139, 23.5.1989, p. 19. Directive as last amended by Directive 92/31/

EEC (OJ No L 126, 12.5.1992, p. 11).(5) OJ No L 246, 17.9.1980, p. 1. Directive as last amended by Directive 84/467/

Euratom (OJ No L 265, 5.10.1984, p. 4).(6) OJ No L 265, 5.10.1984, p. 1.(7) OJ No L 183, 29.6.1989, p. 1.

▼B

whereas such harmonized European standards are drawn up by private-law bodies and should retain their status as non-mandatory texts;whereas, to this end, the European Committee for Standardization(CEN) and the European Committee for Electrotechnical Standardi-zation (Cenelec) are recognized as the competent bodies for theadoption of harmonized standards in accordance with the generalguidelines on cooperation between the Commission and these twobodies signed on 13 November 1984;

Whereas, for the purpose of this Directive, a harmonized standard is atechnical specification (European standard or harmonization document)adopted, on a mandate from the Commission, by either or both of thesebodies in accordance with Council Directive 83/189/EEC of 28 March1983 laying down a procedure for the provision of information in thefield of technical standards and regulations (1), and pursuant to theabovementioned general guidelines; whereas with regard to possibleamendment of the harmonized standards, the Commission should beassisted by the Committee set up pursuant to Directive 83/189/EEC;whereas the measures to be taken must be defined in line withprocedure I, as laid down in Council Decision 87/373/EEC (2);whereas, for specific fields, what already exists in the form ofEuropean Pharmacopoeia monographs should be incorporated withinthe framework of this Directive; whereas, therefore, several EuropeanPharmacopoeia monographs may be considered equal to the abovemen-tioned harmonized standards;

Whereas, in Decision 90/683/EEC of 13 December 1990 concerningthe modules for the various phases of the conformity assessmentprocedures which are intended to be used in the technical harmonizationdirectives (3), the Council has laid down harmonized conformityassessment procedures; whereas the application of these modules tomedical devices enables the responsibility of manufacturers andnotified bodies to be determined during conformity assessmentprocedures on the basis of the type of devices concerned; whereas thedetails added to these modules are justified by the nature of the verifi-cation required for medical devices;

Whereas it is necessary, essentially for the purpose of the conformityassessment procedures, to group the devices into four product classes;whereas the classification rules are based on the vulnerability of thehuman body taking account of the potential risks associated with thetechnical design and manufacture of the devices; whereas theconformity assessment procedures for Class I devices can be carriedout, as a general rule, under the sole responsibility of the manufacturersin view of the low level of vulnerability associated with these products;whereas, for Class IIa devices, the intervention of a notified bodyshould be compulsory at the production stage; whereas, for devicesfalling within Classes IIb and III which constitute a high riskpotential, inspection by a notified body is required with regard to thedesign and manufacture of the devices; whereas Class III is set aside forthe most critical devices for which explicit prior authorization withregard to conformity is required for them to be placed on the market;

Whereas in cases where the conformity of the devices can be assessedunder the responsibility of the manufacturer the competent authoritiesmust be able, particularly in emergencies, to contact a personresponsible for placing the device on the market and established inthe Community, whether the manufacturer or another person establishedin the Community and designated by the manufacturer for the purpose;

Whereas medical devices should, as a general rule, bear the CE mark toindicate their conformity with the provisions of this Directive to enable

1993L0042 — EN — 11.10.2007— 005.001— 4

(1) OJ No L 109, 26.4.1983, p. 8. Directive as last amended by CommissionDecision 92/400/EEC (OJ No L 221, 6.8.1992, p. 55).

(2) OJ No L 197, 18.7.1987, p. 33.(3) OJ No L 147, 9.6.1975, p. 1. Directive as last amended by Directive 91/507/

EEC (OJ No L 270, 26.9.1991, p. 32).

▼B

them to move freely within the Community and to be put into service inaccordance with their intended purpose;

Whereas, in the fight against AIDS and in the light of the conclusionsof the Council adopted on 16 May 1989 regarding future activities onAIDS prevention and control at Community level (1), medical devicesused for protection against the HIV virus must afford a high level ofprotection; whereas the design and manufacture of such products shouldbe verified by a notified body;

Whereas the classification rules generally enable medical devices to beappropriately classified; whereas, in view of the diverse nature of thedevices and technological progress in this field, steps must be taken toinclude amongst the implementing powers conferred on the Commissionthe decisions to be taken with regard to the proper classification orreclassification of the devices or, where appropriate, the adjustment ofthe classification rules themselves; whereas since these issues areclosely connected with the protection of health, it is appropriate thatthese decisions should come under procedure IIIa, as provided for inDirective 87/373/EEC;

Whereas the confirmation of complicance with the essentialrequirements may mean that clinical investigations have to be carriedout under the responsibility of the manufacturer; whereas, for thepurpose of carrying out the clinical investigations, appropriate meanshave to be specified for the protection of public health and public order;

Whereas the protection of health and the associated controls may bemade more effective by means of medical device vigilance systemswhich are integrated at Community level;

Whereas this Directive covers the medical devices referred to in CouncilDirective 76/764/EEC of 27 July 1976 on the approximation of the lawsof the Member States on clinical mercury-in-glass, maximum readingthermometers (2); whereas the abovementioned Directive must thereforebe repealed; whereas for the same reasons Council Directive 84/539/EEC on 17 September 1984 on the approximation of the laws of theMember States relating to electro-medical equipment used in human orveterinary medicine (3) must be amended,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Definitions, scope

1. This Directive shall apply to medical devices and their accessories.For the purposes of this Directive, accessories shall be treated asmedical devices in their own right. Both medical devices and acces-sories shall hereinafter be termed devices.

2. For the purposes of this Directive, the following definitions shallapply:

(a) ►M5 ‘medical device’ means any instrument, apparatus, appliance,software, material or other article, whether used alone or in combi-nation, including the software intended by its manufacturer to beused specifically for diagnostic and/or therapeutic purposes andnecessary for its proper application, intended by the manufacturerto be used for human beings for the purpose of: ◄

— diagnosis, prevention, monitoring, treatment or alleviation ofdisease,

1993L0042 — EN — 11.10.2007— 005.001— 5

(1) OJ No C 185, 22.7.1989, p. 8.(2) OJ No L 262, 27.9.1976, p. 139. Directive as last amended by Directive

84/414/EEC (OJ No L 228, 25.8.1984, p. 25).(3) OJ No L 300, 19.11.1984, p. 179. Directive as amended by the Act of

Accession of Spain and Portugal.

▼B

— diagnosis, monitoring, treatment, alleviation of or compensationfor an injury or handicap,

— investigation, replacement or modification of the anatomy or ofa physiological process,

— control of conception,

and which does not achieve its principal intended action in or onthe human body by pharmacological, immunological or metabolicmeans, but which may be assisted in its function by such means;

(b) ‘accessory’ means an article which whilst not being a device isintended specifically by its manufacturer to be used together witha device to enable it to be used in accordance with the use of thedevice intended by the manufacturer of the device;

▼M1(c) ‘in vitro diagnostic medical device’ means any medical device

which is a reagent, reagent product, calibrator, control material,kit, instrument, apparatus, equipment or system, whether usedalone or in combination, intended by the manufacturer to be usedin vitro for the examination of specimens, including blood andtissue donations,

derived from the human body, solely or principally for the purposeof providing information:

— concerning a physiological or pathological state, or

— concerning a congenital abnormality, or

— to determine the safety and compatibility with potential reci-pients, or

— to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnosticmedical devices. ‘Specimen receptacles’ are those devices,whether vacuum-type or not, specifically intended by their manu-facturers for the primary containment and preservation ofspecimens derived from the human body for the purpose of invitro diagnostic examination.

Products for general laboratory use are not in vitro diagnosticmedical devices unless such products, in view of their character-istics, are specifically intended by their manufacturer to be used forin vitro diagnostic examination;

▼B(d) ‘custom-made device’ means any device specifically made in

accordance with a duly qualified medical practitioner's writtenprescription which gives, under his responsibility, specific designcharacteristics and is intended for the sole use of a particular patient.

The abovementioned prescription may also be made out by anyother person authorized by virtue of his professional qualificationsto do so.

Mass-produced devices which need to be adapted to meet thespecific requirements of the medical practitioner or any otherprofessional user ►M5 shall not be ◄ considered to be custom-made devices;

(e) ‘device intended for clinical investigation’ means any deviceintended for use by a duly qualified medical practitioner whenconducting investigations as referred to in Section 2.1 of AnnexX in an adequate human clinical environment.

For the purpose of conducting clinical investigation, any otherperson who, by virtue of his professional qualifications, isauthorized to carry out such investigation shall be accepted asequivalent to a duly qualified medical practitioner;

1993L0042 — EN — 11.10.2007— 005.001— 6

▼B

(f) ‘manufacturer’ means the natural or legal person with responsibilityfor the design, manufacture, packaging and labelling of a devicebefore it is placed on the market under his own name, regardless ofwhether these operations are carried out by that person himself oron his behalf by a third party.

The obligations of this Directive to be met by manufacturers alsoapply to the natural or legal person who assembles, packages,processes, fully refurbishes and/or labels one or more ready-madeproducts and/or assigns to them their intended purpose as a devicewith a view to their being placed on the market under his ownname. This subparagraph does not apply to the person who, whilenot a manufacturer within the meaning of the first subparagraph,assembles or adapts devices already on the market to their intendedpurpose for an individual patient;

(g) ‘intended purpose’ means the use for which the device is intendedaccording to the data supplied by the manufacturer on the labelling,in the instructions and/or in promotional materials;

(h) ‘placing on the market’ means the first making available in returnfor payment or free of charge of a device other than a deviceintended for clinical investigation, with a view to distributionand/or use on the Community market, regardless of whether it isnew or fully refurbished;

▼M1(i) ‘putting into service’ means the stage at which a device has been

made available to the final user as being ready for use on theCommunity market for the first time for its intended purpose;

(j) ‘authorised representative’ means any natural or legal person estab-lished in the Community who, explicitly designated by the manu-facturer, acts and may be addressed by authorities and bodies in theCommunity instead of the manufacturer with regard to the latter'sobligations under this Directive;

▼M5(k) ‘clinical data’ means the safety and/or performance information that

is generated from the use of a device. Clinical data are sourcedfrom:

— clinical investigation(s) of the device concerned; or

— clinical investigation(s) or other studies reported in thescientific literature, of a similar device for which equivalenceto the device in question can be demonstrated; or

— published and/or unpublished reports on other clinicalexperience of either the device in question or a similar devicefor which equivalence to the device in question can be demon-strated;

(l) ‘device subcategory’ means a set of devices having common areasof intended use or common technology;

(m) ‘generic device group’ means a set of devices having the same orsimilar intended uses or commonality of technology allowing themto be classified in a generic manner not reflecting specific charac-teristics;

(n) ‘single use device’ means a device intended to be used once onlyfor a single patient.

3. Where a device is intended to administer a medicinal productwithin the meaning of Article 1 of Directive 2001/83/EC (1), that

1993L0042 — EN — 11.10.2007— 005.001— 7

(1) Directive 2001/83/EC of the European Parliament and of the Council of6 November 2001 on the Community code relating to medicinal productsfor human use (OJ L 311, 28.11.2001, p. 67). Directive as last amended byRegulation (EC) No 1901/2006 (OJ L 378, 27.12.2006, p. 1).

▼M5

device shall be governed by this Directive, without prejudice to theprovisions of Directive 2001/83/EC with regard to the medicinalproduct.

If, however, such a device is placed on the market in such a way thatthe device and the medicinal product form a single integral productwhich is intended exclusively for use in the given combination andwhich is not reusable, that single product shall be governed byDirective 2001/83/EC. The relevant essential requirements of Annex Ito this Directive shall apply as far as safety and performance-relateddevice features are concerned.

▼B4. Where a device incorporates, as an integral part, a substance which,if used separately, may be considered to be a medicinal productwithin the meaning of Article 1 of Directive ►M5 2001/83/EC ◄ andwhich is liable to act upon the body with action ancillary to that of thedevice, ►M5 that device shall ◄ be assessed and authorized inaccordance with this Directive.

▼M24 a. Where a device incorporates, as an integral part, a substancewhich, if used separately, may be considered to be a medicinalproduct constituent or a medicinal product derived from human bloodor human plasma within the meaning of Article 1 of Directive►M5 2001/83/EC ◄ and which is liable to act upon the humanbody with action ancillary to that of the device, hereinafter referred toas a ‘human blood derivative’, ►M5 that device shall ◄ be assessedand authorised in accordance with this Directive.

▼B5. ►M5 This Directive shall not apply to: ◄

(a) in vitro diagnostic devices;

(b) active implantable devices covered by Directive 90/385/EEC;

▼M5(c) medicinal products covered by Directive 2001/83/EC. In deciding

whether a product falls under that Directive or this Directive,particular account shall be taken of the principal mode of actionof the product;

▼B(d) cosmetic products covered by Directive 76/768/EEC (1);

▼M3(e) human blood, blood products, plasma or blood cells of human

origin or to devices which incorporate at the time of placing onthe market such blood products, plasma or cells, with the exceptionof devices referred to in paragraph 4a;

▼M5(f) transplants or tissues or cells of human origin nor to products

incorporating or derived from tissues or cells of human origin,with the exception of devices referred to in paragraph 4a;

▼B(g) transplants or tissues or cells of animal origin, unless a device is

manufactured utilizing animal tissue which is rendered non-viable ornon-viable products derived from animal tissue.

1993L0042 — EN — 11.10.2007— 005.001— 8

(1) OJ No L 262, 27.9.1976, p. 169. Directive as last amended by CommissionDirective 92/86/EEC (OJ No L 325, 11.11.1992, p. 18).

▼M5

6. Where a device is intended by the manufacturer to be used inaccordance with both the provisions on personal protective equipmentin Council Directive 89/686/EEC (1) and this Directive, the relevantbasic health and safety requirements of Directive 89/686/EEC shallalso be fulfilled.

7. This Directive is a specific Directive within the meaning ofArticle 1(4) of Directive 2004/108/EC of the European Parliament andof the Council (2).

8. This Directive shall not affect the application of Council Directive96/29/Euratom of 13 May 1996 laying down basic safety standards forthe protection of the health of workers and the general public against thedangers arising from ionising radiation (3), nor of Council Directive97/43/Euratom of 30 June 1997 on health protection of individualsagainst the dangers of ionising radiation in relation to medicalexposure (4).

▼M1

Article 2

Placing on the market and putting into service

Member States shall take all necessary steps to ensure that devices maybe placed on the market and/or put into service only if they comply withthe requirements laid down in this Directive when duly supplied andproperly installed, maintained and used in accordance with theirintended purpose.

▼B

Article 3

Essential requirements

The devices must meet the essential requirements set out in Annex Iwhich apply to them, taking account of the intended purpose of thedevices concerned.

▼M5Where a relevant hazard exists, devices which are also machinery withinthe meaning of Article 2(a) of Directive 2006/42/EC of the EuropeanParliament and of the Council of 17 May 2006 on machinery (5) shallalso meet the essential health and safety requirements set out in Annex Ito that Directive to the extent to which those essential health and safetyrequirements are more specific than the essential requirements set out inAnnex I to this Directive.

▼B

Article 4

Free movement, devices intended for special purposes

1. Member States shall not create any obstacle to the placing on themarket or the putting into service within their territory of devicesbearing the CE marking provided for in Article 17 which indicate

1993L0042 — EN — 11.10.2007— 005.001— 9

(1) Council Directive 89/686/EEC of 21 December 1989 on the approximation ofthe laws of the Member States relating to personal protective equipment (OJL 399, 30.12.1989, p. 18). Directive as last amended by Regulation (EC)No 1882/2003 of the European Parliament and of the Council (OJ L 284,31.10.2003, p. 1).

(2) Directive 2004/108/EC of the European Parliament and of the Council of15 December 2004 on the approximation of the laws of the Member Statesrelating to electromagnetic compatibility (OJ L 390, 31.12.2004, p. 24).

(3) OJ L 159, 29.6.1996, p. 1.(4) OJ L 180, 9.7.1997, p. 22.(5) OJ L 157, 9.6.2006, p. 24.

▼B

that they have been the subject of an assessment of their conformity inaccordance with the provisions of Article 11.

2. Member States shall not create any obstacle to:

— devices intended for clinical investigation being made available tomedical practitioners or authorized persons for that purpose if theymeet the conditions laid down in Article 15 and in Annex VIII,

▼M5— custom-made devices being placed on the market and put into

service if they meet the conditions laid down in Article 11 incombination with Annex VIII; Class IIa, IIb and III devices shallbe accompanied by the statement referred to in Annex VIII, whichshall be available to the particular patient identified by name, anacronym or a numerical code.

▼BThese devices shall not bear the CE marking.

3. At trade fairs, exhibitions, demonstrations, etc. Member Statesshall not create any obstacle to the showing of devices which do notconform to this Directive, provided that a visible sign clearly indicatesthat such devices cannot be marketed or put into service until they havebeen made to comply.

4. Member States may require the information, which must be madeavailable to the user and the patient in accordance with Annex I, point13, to be in their national language(s) or in another Communitylanguage, when a device reaches the final user, regardless of whetherit is for professional or other use.

5. Where the devices are subject to other Directives concerning otheraspects and which also provide for the affixing of the CE marking, thelatter shall indicate that the devices also fulfil the provisions of the otherDirectives.

However, should one or more of these directives allow the manu-facturer, during a transitional period, to choose which arrangements toapply, the CE marking shall indicate that the devices fulfil theprovisions only of those directives applied by the manufacturer. Inthis case, the particulars of these directives, as published in theOfficial Journal of the European Communities, must be given in thedocuments, notices or instructions required by the directives and accom-panying such devices.

Article 5

Reference to standards

1. Member States shall presume compliance with the essentialrequirements referred to in Article 3 in respect of devices which arein conformity with the relevant national standards adopted pursuant tothe harmonized standards the references of which have been publishesin the Official Journal of the European Communities; Member Statesshall publish the references of such national standards.

2. For the purposes of this Directive, reference to harmonizedstandards also includes the monographs of the European Pharma-copoeia notably on surgical sutures and on interaction betweenmedicinal products and materials used in devices containing suchmedicinal products, the references of which have been published inthe Official Journal of the European Communities.

3. If a Member State or the Commission considers that theharmonized standards do not entirely meet the essential requirementsreferred to in Article 3, the measures to be taken by the Member Stateswith regard to these standards and the publication referred to in

1993L0042 — EN— 11.10.2007— 005.001— 10

▼B

paragraph 1 of this Article shall be adopted by the procedure defined inArticle 6 (2).

▼M4

Article 6

Committee on Standards and Technical Regulations

1. The Commission shall be assisted by the Committee set up byArticle 5 of Directive ►M5 98/34/EC (1) ◄, hereinafter referred to as‘the Committee’.

2. Where reference is made to this Article, Articles 3 and 7 ofDecision 1999/468/EC (2) shall apply, having regard to the provisionsof Article 8 thereof.

3. The Committee shall adopt its rules of procedure.

▼M5

Article 7

1. The Commission shall be assisted by the Committee set up byArticle 6(2) of Directive 90/385/EEC, hereinafter referred to as ‘theCommittee’.

2. Where reference is made to this paragraph, Articles 5 and 7 ofDecision 1999/468/EC shall apply, having regard to the provisions ofArticle 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall beset at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) andArticle 7 of Decision 1999/468/EC shall apply, having regard to theprovisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a(1), (2), (4)and (6) and Article 7 of Decision 1999/468/EC shall apply, havingregard to the provisions of Article 8 thereof.

▼B

Article 8

Safeguard clause

1. Where a Member State ascertains that the devices referred to inArticle 4 (1) and (2) second indent, when correctly installed, maintainedand used for their intended purpose, may compromise the health and/orsafety of patients, users or, where applicable, other persons, it shall takeall appropriate interim measures to withdraw such devices from themarket or prohibit or restrict their being placed on the market or putinto service. The Member State shall immediately inform theCommission of any such measures, indicating the reasons for itsdecision and, in particular, whether non-compliance with thisDirective is due to:

(a) failure to meet the essential requirements referred to in Article 3;

(b) incorrect application of the standards referred to in Article 5, in sofar as it is claimed that the standards have been applied;

1993L0042— EN— 11.10.2007 — 005.001 — 11

(1) Directive 98/34/EC of the European Parliament and of the Council of 22 June1998 laying down a procedure for the provision of information in the field oftechnical standards and regulations and of rules on Information Societyservices (OJ L 204, 21.7.1998, p. 37). Directive as last amended by the2003 Act of Accession.

(2) Council Decision 1999/468/EC of 28 June 1999 laying down the proceduresfor the exercise of implementing powers conferred on the Commission (OJL 184, 17.7.1999, p. 23).

▼B

(c) shortcomings in the standards themselves.

▼M52. The Commission shall enter into consultation with the Partiesconcerned as soon as possible. Where, after such consultation, theCommission finds that:

(a) the measures are justified:

(i) it shall immediately so inform the Member State which took themeasures and the other Member States. Where the decisionreferred to in paragraph 1 is attributed to shortcomings in thestandards, the Commission shall, after consulting the Partiesconcerned, bring the matter before the Committee referred toin Article 6(1) within two months if the Member State whichhas taken the decision intends to maintain it and shall initiatethe advisory procedure referred to in Article 6(2);

(ii) when necessary in the interests of public health, appropriatemeasures designed to amend non-essential elements of thisDirective relating to withdrawal from the market of devicesreferred to in paragraph 1 or to prohibition or restriction oftheir placement on the market or being put into service or tointroduction of particular requirements in order for suchproducts to be put on the market, shall be adopted inaccordance with the regulatory procedure with scrutinyreferred to in Article 7(3). On imperative grounds of urgency,the Commission may use the urgency procedure referred to inArticle 7(4);

(b) the measures are unjustified, it shall immediately so inform theMember State which took the measures and the manufacturer orhis authorised representative.

▼B3. Where a non-complying device bears the CE marking, thecompetent Member State shall take appropriate action against whom-soever has affixed the mark and shall inform the Commission and theother Member States thereof.

4. The Commission shall ensure that the Member States are keptinformed of the progress and outcome of this procedure.

Article 9

Classification

1. Devices shall be divided into Classes I, IIa, IIb and III. Classifi-cation shall be carried out in accordance with Annex IX.

2. In the event of a dispute between the manufacturer and thenotified body concerned, resulting from the application of the classifi-cation rules, the matter shall be referred for decision to the competentauthority to which the notified body is subject.

▼M53. Where a Member State considers that the classification rules setout in Annex IX require adaptation in the light of technical progress andany information which becomes available under the information systemprovided for in Article 10, it may submit a duly substantiated request tothe Commission and ask it to take the necessary measures for adaptationof classification rules. The measures designed to amend non-essentialelements of this Directive relating to adaptation of classification rulesshall be adopted in accordance with the regulatory procedure withscrutiny referred to in Article 7(3).

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Article 10

Information on incidents occuring following placing of devices onthe market

1. Member States shall take the necessary steps to ensure that anyinformation brought to their knowledge, in accordance with theprovisions of this Directive, regarding the incidents mentioned belowinvolving a Class I, IIa, IIb or III device is recorded and evaluatedcentrally:

(a) any malfunction or deterioration in the characteristics and/orperformance of a device, as well as any inadequacy in thelabelling or the instructions for use which might lead to or mighthave led to the death of a patient or user or to a serious dete-rioration in his state of health;

(b) any technical or medical reason in relation to the characteristics orperformance of a device for the reasons referred to in subparagraph(a), leading to systematic recall of devices of the same type by themanufacturer.

2. Where a Member State requires medical practitioners or themedical institutions to inform the competent authorities of anyincidents referred to in paragraph 1, it shall take the necessary stepsto ensure that the manufacturer of the device concerned, or hisauthorized representative ►M5 __________ ◄, is also informed ofthe incident.

▼M53. After carrying out an assessment, if possible together with themanufacturer or his authorised representative, Member States shall,without prejudice to Article 8, immediately inform the Commissionand the other Member States of measures that have been taken or arecontemplated to minimise the recurrence of the incidents referred to inparagraph 1, including information on the underlying incidents.

4. Any appropriate measures to adopt procedures to implement thisArticle shall be adopted in accordance with the regulatory procedurereferred to in Article 7(2).

▼B

Article 11

Conformity assessment procedures

1. In the case of devices falling within Class III, other than deviceswhich are custom-made or intended for clinical investigations, themanufacturer shall, in order to affix the CE marking, either:

(a) follow the procedure relating to the EC declaration of conformityset out in Annex II (full quality assurance); or

(b) follow the procedure relating to the EC type-examination set out inAnnex III, coupled with:

(i) the procedure relating to the EC verification set out in AnnexIV;

or

(ii) the procedure relating to the EC declaration of conformity setout in Annex V (production quality assurance).

2. In the case of devices falling within Class IIa, other than deviceswhich are custom-made or intended for clinical investigations, themanufacturer shall, in order to affix the CE marking, follow theprocedure relating to the EC declaration of conformity set out inAnnex VII, coupled with either:

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(a) the procedure relating to the EC verification set out in Annex IV;

or

(b) the procedure relating to the EC declaration of conformity set out inAnnex V (production quality assurance);

or

(c) the procedure relating to the EC declaration of conformity set out inAnnex VI (product quality assurance).

Instead of applying these procedures, the manufacturer may also followthe procedure referred to in paragraph 3 (a).

3. In the case of devices falling within Class IIb, other than deviceswhich are custom-made or intended for clinical investigations, themanufacturer shall, in order to affix the CE marking, either:

(a) follow the procedure relating to the EC declaration of conformityset out in Annex II (full quality assurance); in this case, point 4 ofAnnex II is not applicable; or

(b) follow the procedure relating to the EC type-examination set out inAnnex III, coupled with:

(i) the procedure relating to the EC verification set out in AnnexIV;

or

(ii) the procedure relating to the EC declaration of conformity setout in Annex V (production quality assurance);

or

(iii) the procedure relating to the EC declaration of conformity setout in Annex VI (product quality assurance).

4. The Commission shall, no later than five years from the date ofimplementation of this Directive, submit a report to the Council on theoperation of the provisions referred to in Article 10 (1), Article 15 (1),in particular in respect of Class I and Class IIa devices, and on theoperation of the provisions referred to in Annex II, Section 4.3 secondand third subparagraphs and in Annex III, Section 5 second and thirdsubparagraphs to this Directive, accompanied, if necessary, by appro-priate proposals.

5. In the case of devices falling within Class I, other than deviceswhich are custom-made or intended for clinical investigations, themanufacturer shall, in order to affix the CE marking, follow theprocedure referred to in Annex VII and draw up the EC declarationof conformity required before placing the device on the market.

6. In the case of custom-made devices, the manufacturer shall followthe procedure referred to in Annex VIII and draw up the statement setout in that Annex before placing each device on the market.

Member States may require that the manufacturer shall submit to thecompetent authority a list of such devices which have been put intoservice in their territory.

7. During the conformity assessment procedure for a device, themanufacturer and/or the notified body shall take account of the resultsof any assessment and verification operations which, where appropriate,have been carried out in accordance with this Directive at an inter-mediate stage of manufacture.

8. The manufacturer may instruct his authorized representative►M5 __________ ◄ to initiate the procedures provided for inAnnexes III, IV, VII and VIII.

9. Where the conformity assessment procedure involves the inter-vention of a notified body, the manufacturer, or his authorized repre-

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sentative ►M5 __________ ◄, may apply to a body of his choicewithin the framework of the tasks for which the body has been notified.

10. The notified body may require, where duly justified, any infor-mation or data, which is necessary for establishing and maintaining theattestation of conformity in view of the chosen procedure.

11. Decisions taken by the notified bodies in accordance with►M5 Annexes II, III, V and VI ◄ shall be valid for a maximum offive years and may be extended on application, made at a time agreed inthe contract signed by both parties, ►M5 for further periods of amaximum length of five years ◄.

12. The records and correspondence relating to the proceduresreferred to in paragraphs 1 to 6 shall be in an official language of theMember State in which the procedures are carried out and/or in anotherCommunity language acceptable to the notified body.

13. By derogation from paragraphs 1 to 6, the competent authoritiesmay authorize, on duly justified request, the placing on the market andputting into service, within the territory of the Member State concerned,of individual devices for which the procedures referred to in paragraphs1 to 6 have not been carried out and the use of which is in the interestof protection of health.

▼M514. The measures designed to amend non-essential elements of thisDirective, by supplementing it, relating to the means by which, in thelight of technical progress and considering the intended users of thedevices concerned, the information laid down in Annex ISection 13.1 may be set out, shall be adopted in accordance with theregulatory procedure with scrutiny referred to in Article 7(3).

▼B

Article 12

►M5 Particular procedure for systems and procedure packs andprocedure for sterilisation ◄

1. By way of derogation from Article 11 this Article shall apply tosystems and procedure packs.

2. Any natural or legal person who puts devices bearing the CEmarking together within their intended purpose and within the limitsof use specified by their manufacturers, in order to place them on themarket as a system or procedure pack, shall draw up a declaration bywhich he states that:

(a) he has verified the, mutual compatibility of the devices inaccordance with the manufacturers' instructions and has carriedout his operations in accordance with these instructions; and

(b) he has packaged the system or procedure pack and supplied relevantinformation to users incorporating relevant instructions from themanufacturers; and

(c) the whole activity is subjected to appropriate methods of internalcontrol and inspection.

Where the conditions above are not met, as in cases where the system orprocedure pack incorporate devices which do not bear a CE marking orwhere the chosen combination of devices is not compatible in view oftheir original intended use, the system or procedure pack shall be treatedas a device in its own right and as such be subjected to the relevantprocedure pursuant to Article 11.

▼M53. Any natural or legal person who sterilises, for the purpose ofplacing on the market, systems or procedure packs referred to inparagraph 2 or other CE-marked medical devices designed by their

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manufacturers to be sterilised before use, shall, at his choice, follow oneof the procedures referred to in Annex II or V. The application of theabovementioned Annexes and the intervention of the notified body arelimited to the aspects of the procedure relating to the obtaining ofsterility until the sterile package is opened or damaged. The personshall draw up a declaration stating that sterilisation has been carriedout in accordance with the manufacturer's instructions.

▼B4. The products referred to in paragraphs 2 and 3 themselves shallnot bear an additional CE marking. They shall be accompanied by theinformation referred to in point 13 of Annex I which includes, whereappropriate, the information supplied by the manufacturers of thedevices which have been put together. ►M5 The declarationsreferred to in paragraphs 2 and 3 shall be kept at the disposal of thecompetent authorities for a period of five years. ◄

▼M5

Article 12a

Reprocessing of medical devices

The Commission shall, no later than 5 September 2010, submit a reportto the European Parliament and to the Council on the issue of thereprocessing of medical devices in the Community.

In the light of the findings of this report, the Commission shall submitto the European Parliament and to the Council any additional proposal itmay deem appropriate in order to ensure a high level of healthprotection.

Article 13

Decisions with regard to classification and derogation clause

1. A Member State shall submit a duly substantiated request to theCommission and ask it to take the necessary measures in the followingsituations:

(a) that Member State considers that the application of the classificationrules set out in Annex IX requires a decision with regard to theclassification of a given device or category of devices;

(b) that Member State considers that a given device or family ofdevices should, by way of derogation from the provisions ofAnnex IX, be classified in another class;

(c) that Member State considers that the conformity of a device orfamily of devices should, by way of derogation from Article 11,be established by applying solely one of the given procedureschosen from among those referred to in Article 11;

(d) that Member State considers that a decision is required as towhether a particular product or product group falls within one ofthe definitions in Article 1(2)(a) to (e).

The measures referred to in the first subparagraph of this paragraphshall, as appropriate, be adopted in accordance with the procedurereferred to in Article 7(2).

2. The Commission shall inform the Member States of the measurestaken.

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Article 14

Registration of persons responsible for placing devices on themarket

1. Any manufacturer who, under his own name, places devices onthe market in accordance with the procedures referred to in Article 11(5) and (6) and any other natural or legal person engaged in theactivities referred to in Article 12 shall inform the competent authoritiesof the Member State in which he has his registered place of business ofthe address of the registered place of business and the description of thedevices concerned.

▼M1For all medical devices of ►M5 classes IIa, IIb and III ◄, MemberStates may request to be informed of all data allowing for identificationof such devices together with the label and the instructions for use whensuch devices are put into service within their territory.

▼M52. Where a manufacturer who places a device on the market underhis own name does not have a registered place of business in a MemberState, he shall designate a single authorised representative in theEuropean Union. For devices referred to in the first subparagraph ofparagraph 1, the authorised representative shall inform the competentauthority of the Member State in which he has his registered place ofbusiness of the details referred to in paragraph 1.

3. The Member States shall on request inform the other Member Statesand the Commission of the details referred to in the first subparagraph ofparagraph 1 given by the manufacturer or authorised representative.

▼M1

Article 14a

European databank

1. Regulatory data in accordance with this Directive shall be storedin a European database accessible to the competent authorities to enablethem to carry out their tasks relating to this Directive on a well-informed basis.

The databank shall contain the following:

▼M5(a) data relating to registration of manufacturers and authorised repre-

sentatives and devices in accordance with Article 14 excluding datarelated to custom-made devices;

▼M1(b) data relating to certificates issued, modified, supplemented,

suspended, withdrawn or refused according to the procedures, aslaid down in Annexes II to VII;

(c) data obtained in accordance with the vigilance procedure as definedin Article 10;

▼M5(d) data relating to clinical investigations referred to in Article 15.

▼M12. Data shall be forwarded in a standardised format.

▼M53. The measures necessary for the implementation of paragraphs 1and 2 of this Article, in particular paragraph 1(d), shall be adopted inaccordance with the regulatory procedure referred to in Article 7(2).

4. The provisions of this Article shall be implemented no later than5 September 2012. The Commission shall, no later than 11 October2012, evaluate the operational functioning and the added value of the

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databank. On the basis of this evaluation, the Commission shall, ifappropriate, present proposals to the European Parliament and theCouncil or present draft measures in accordance with paragraph 3.

Article 14b

Particular health monitoring measures

Where a Member State considers, in relation to a given product orgroup of products, that, in order to ensure protection of health andsafety and/or to ensure that public health requirements are observed,such products should be withdrawn from the market, or their placingon the market and putting into service should be prohibited, restricted orsubjected to particular requirements, it may take any necessary andjustified transitional measures.

The Member State shall then inform the Commission and all otherMember States, giving the reasons for its decision.

The Commission shall, whenever possible, consult the interested Partiesand the Member States.

The Commission shall adopt its opinion, indicating whether the nationalmeasures are justified or not. The Commission shall inform all theMember States and the consulted interested Parties thereof.

When appropriate, the necessary measures designed to amend non-essential elements of this Directive, relating to withdrawal from themarket, prohibition of placing on the market and putting into serviceof a certain product or group of products or to restrictions or intro-duction of particular requirements in order for such products to be puton the market, shall be adopted in accordance with the regulatoryprocedure with scrutiny referred to in Article 7(3). On imperativegrounds of urgency, the Commission may use the urgency procedurereferred to in Article 7(4).

▼B

Article 15

Clinical investigation

▼M51. In the case of devices intended for clinical investigations, themanufacturer or the authorised representative, established in theCommunity, shall follow the procedure referred to in Annex VIII andnotify the competent authorities of the Member States in which theinvestigations are to be conducted by means of the statementmentioned in Section 2.2 of Annex VIII.

2. In the case of devices falling within Class III and implantable andlong-term invasive devices falling within Class IIa or IIb, the manu-facturer may commence the relevant clinical investigation at the end ofa period of 60 days after notification, unless the competent authoritieshave notified him within that period of a decision to the contrary basedon considerations of public health or public policy.

Member States may however authorise manufacturers to commence therelevant clinical investigations before the expiry of the period of 60days, insofar as the relevant ethics committee has issued a favourableopinion on the programme of investigation in question, including itsreview of the clinical investigation plan.

3. In the case of devices other than those referred to in paragraph 2,Member States may authorise manufacturers to commence clinicalinvestigations immediately after the date of notification, provided thatthe ethics committee concerned has issued a favourable opinion on theprogramme of investigation in question including its review of theclinical investigation plan.

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4. The authorization referred to in paragraph 2 second subparagraphand paragraph 3, may be made subject to authorization from thecompetent authority.

▼M55. The clinical investigations must be conducted in accordance withthe provisions of Annex X. The measures designed to amend non-essential elements of this Directive, inter alia by supplementing it,relating to the provisions on clinical investigation in Annex X shallbe adopted in accordance with the regulatory procedure with scrutinyreferred to in Article 7(3).

6. The Member States shall, if necessary, take the appropriate stepsto ensure public health and public policy. Where a clinical investigationis refused or halted by a Member State, that Member State shallcommunicate its decision and the grounds therefor to all MemberStates and the Commission. Where a Member State has called for asignificant modification or temporary interruption of a clinical investi-gation, that Member State shall inform the Member States concernedabout its actions and the grounds for the actions taken.

7. The manufacturer or his authorised representative shall notify thecompetent authorities of the Member States concerned of the end of theclinical investigation, with a justification in case of early termination. Inthe case of early termination of the clinical investigation on safetygrounds this notification shall be communicated to all Member Statesand the Commission. The manufacturer or his authorised representativeshall keep the report referred to in Section 2.3.7 of Annex X at thedisposal of the competent authorities.

▼B8. The provisions of paragraphs 1 and 2 do not apply where theclinical investigations are conducted using devices which are authorizedin accordance with Article 11 to bear the CE marking unless the aim ofthese investigations is to use the devices for a purpose other than thatreferred to in the relevant conformity assessment procedure. Therelevant provisions of Annex X remain applicable.

Article 16

Notified bodies

1. The Member States shall notify the Commission and otherMember States of the bodies which they have designated for carryingout the tasks pertaining to the procedures referred to in Article 11 andthe specific tasks for which the bodies have been designated. TheCommission shall assign identification numbers to these bodies, here-inafter referred to as ‘notified bodies’.

The Commission shall publish a list of the notified bodies, together withthe identification numbers it has allocated to them and the tasks forwhich they have been notified, in the Official Journal of the EuropeanCommunities. It shall ensure that the list is kept up to date.

2. Member States shall apply the criteria set out in Annex XI for thedesignation of bodies. Bodies that meet the criteria laid down in thenational standards which transpose the relevant harmonized standardsshall be presumed to meet the relevant criteria.

▼M5When appropriate in the light of technical progress, the detailedmeasures necessary to ensure a consistent application of the criteriaset out in Annex XI for the designation of bodies by the MemberStates shall be adopted in accordance with the regulatory procedurereferred to in Article 7(2).

▼B3. A Member State that has notified a body shall withdraw thatnotification if it finds that the body no longer meets the criteria

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referred to in paragraph 2. It shall immediately inform the otherMember States and the Commission thereof.

4. The notified body and the manufacturer, or his authorized repre-sentative ►M5 __________ ◄, shall lay down, by common accord,the time limits for completion of the assessment and verificationoperations referred to in Annexes II to VI.

▼M55. The notified body shall inform its competent authority about allcertificates issued, modified, supplemented, suspended, withdrawn orrefused and the other notified bodies within the scope of thisDirective about certificates suspended, withdrawn or refused and, onrequest, about certificates issued. The notified body shall also makeavailable, on request, all additional relevant information.

▼M16. Where a notified body finds that pertinent requirements of thisDirective have not been met or are no longer met by the manufactureror where a certificate should not have been issued, it shall, takingaccount of the principle of proportionality, suspend or withdraw thecertificate issued or place any restrictions on it unless compliancewith such requirements is ensured by the implementation of appropriatecorrective measures by the manufacturer. In the case of suspension orwithdrawal of the certificate or of any restriction placed on it or in caseswhere an intervention of the competent authority may becomenecessary, the notified body shall inform its competent authoritythereof. The Member State shall inform the other Member States andthe Commission.

7. The notified body shall, on request, supply all relevant informationand documents including budgetary documents, required to enable theMember State to verify compliance with Annex XI requirements.

▼B

Article 17

CE marking

1. Devices, other than devices which are custom-made or intendedfor clinical investigations, considered to meet the essential requirementsreferred to in Article 3 must bear the CE marking of conformity whenthey are placed on the market.

2. The CE marking of conformity, as shown in Annex XII, mustappear in a visible, legible and indelible form on the device or itssterile pack, where practicable and appropriate, and on the instructionsfor use. Where applicable, the CE marking must also appear on the salespackaging.

It shall be accompanied by the identification number of the notifiedbody responsible for implementation of the procedures set out inAnnexes II, IV, V and VI.

3. It is prohibited to affix marks or inscriptions which are likely tomislead third parties with regard to the meaning or the graphics of theCE marking. Any other mark may be affixed to the device, to thepackaging or to the instruction leaflet accompanying the deviceprovided that the visibility and legibility of the CE marking is notthereby reduced.

Article 18

Wrongly affixed CE marking

Without prejudice to Article 8:

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(a) where a Member State establishes that the CE marking has beenaffixed unduly or is missing in violation of the Directive, the manu-facturer or his authorised representative shall be obliged to end theinfringement under conditions imposed by the Member State;

▼B(b) where non-compliance continues, the Member State must take all

appropriate measures to restrict or prohibit the placing on themarket of the product in question or to ensure that it iswithdrawn from the market, in accordance with the procedure inArticle 8.

▼M1Those provisions shall also apply where the CE marking has beenaffixed in accordance with the procedures in this Directive, but inap-propriately, on products that are not covered by this Directive.

▼B

Article 19

Decision in respect of refusal or restriction

1. Any decision taken pursuant to this Directive:

(a) to refuse or restrict the placing on the market or the putting intoservice of a device or the carrying out of clinical investigations;

or

(b) to withdraw devices from the market,

shall state the exact grounds on which it is based. Such decisions shallbe notified without delay to the party concerned, who shall at the sametime be informed of the remedies available to him under the nationallaw in force in the Member State in question and of the time limits towhich such remedies are subject.

2. In the event of a decision as referred to in paragraph 1, themanufacturer, or his authorized representative ►M5 __________ ◄,shall have an opportunity to put forward his viewpoint in advance,unless such consultation is not possible because of the urgency of themeasure to be taken.

▼M5

Article 20

Confidentiality

1. Without prejudice to the existing national provisions and practiceson medical confidentiality, Member States shall ensure that all theParties involved in the application of this Directive are bound toobserve confidentiality with regard to all information obtained incarrying out their tasks.

This does not affect the obligation of Member States and notified bodieswith regard to mutual information and the dissemination of warnings,nor the obligations of the persons concerned to provide informationunder criminal law.

2. The following information shall not be treated as confidential:

(a) information on the registration of persons responsible for placingdevices on the market in accordance with Article 14;

(b) information to users sent out by the manufacturer, authorised repre-sentative or distributor in relation to a measure according toArticle 10(3);

(c) information contained in certificates issued, modified, supple-mented, suspended or withdrawn.

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3. The measures designed to amend non-essential elements of thisDirective, inter alia by supplementing it, relating to determination of theconditions under which other information may be made publiclyavailable, and in particular for Class IIb and Class III devices to anyobligation for manufacturers to prepare and make available a summaryof the information and data related to the device, shall be adopted inaccordance with the regulatory procedure with scrutiny referred to inArticle 7(3).

Article 20a

Cooperation

Member States shall take appropriate measures to ensure that thecompetent authorities of the Member States cooperate with each otherand with the Commission and transmit to each other the informationnecessary to enable this Directive to be applied uniformly.

The Commission shall provide for the organisation of an exchange ofexperience between the competent authorities responsible for marketsurveillance in order to coordinate the uniform application of thisDirective.

Without prejudice to the provisions of this Directive, cooperation maybe part of initiatives developed at an international level.

▼B

Article 21

Repeal and amendment of Directives

1. Directive 76/764/EEC is hereby repealed with effect from 1January 1995.

2. In the title and Article 1 of Directive 84/539/EEC, ‘human or’ isdeleted.

In Article 2 of Directive 84/539/EEC, the following subparagraph isadded to paragraph 1:

‘If the appliance is at the same time a medical device within themeaning of Directive 93/42/EEC (*) and if it satisfies the essentialrequirements laid down therein for that device, the device shall bedeemed to be in conformity with the requirements of this Directive.___________(*) OJ No L 169, 12.7.1993, p. 1.’

3. Directive 90/385/EEC is hereby amended as follows:

1. in Article 1 (2) the following two subparagraphs are added:

‘(h) “placing on the market” means the first making available inreturn for payment or free of charge of a device other than adevice intended for clinical investigation, with a view to distri-bution and/or use on the Community market, regardless ofwhether it is new or fully refurbished;

(i) “manufacturer” means the natural or legal person with respon-sibility for the design, manufacture, packaging and labelling ofa device before it is placed on the market under his own name,regardless of whether these operations are carried out by thatperson himself or on his behalf by a third party.

The obligations of this Directive to be met by manufacturersalso apply to the natural or legal person who assembles,packages, processes, fully refurbishes and/or labels one ormore ready-made products and/or assigns to them theirintended purpose as a device with a view to their beingplaced on the market under his own name. This subparagraph

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does not apply to the person who, while not a manufacturerwithin the meaning of the first subparagraph, assembles oradapts devices already on the market to their intendedpurpose for an individual patient;’

2. in Article 9 the following paragraphs are added:

‘5. During the conformity assessment procedure for a device, themanufacturer and/or the notified body shall take account of theresults of any assessment and verification operations which, whereappropriate, have been carried out in accordance with this Directiveat an intermediate stage of manufacture.

6. Where the conformity assessment procedure involves the inter-vention of a notified body, the manufacturer, or his authorized repre-sentative established in the Community, may apply to a body of hischoice within the framework of the tasks for which the body hasbeen notified.

7. The notified body may require, where duly justified, any infor-mation or data which is necessary for establishing and maintainingthe attestation of conformity in view of the chosen procedure.

8. Decisions taken by the notified bodies in accordance withAnnexes II and III shall be valid for a maximum of five yearsand may be extended on application, made at a time agreed in thecontract signed by both parties, for further periods of five years.

9. By derogation from paragraphs 1 and 2 the competent autho-rities may authorize, on duly justified request, the placing on themarket and putting into service, within the territory of the MemberState concerned, of individual devices for which the proceduresreferred to in paragraphs 1 and 2 have not been carried out andthe use of which is in the interest of protection of health.’;

3. the following Article 9a is inserted after Article 9:

‘Article 9a

1. Where a Member State considers that the conformity of adevice or family of devices should be established, by way of dero-gation from the provisions of Article 9, by applying solely one ofthe given procedures chosen from among those referred to in Article9, it shall submit a duly substantiated request to the Commission andask it to take the necessary measures. These measures shall beadopted in accordance with the procedure referred to in Article 7(2) of Directive 93/42/EEC (*).

2. The Commission shall inform the Member States of themeasures taken and, where appropriate, publish the relevant partsof these measures in the Official Journal of the European Commu-nities.___________(*) OJ No L 169, 12.7.1993, p. 1.’

4. Article 10 shall be amended as follows:

— the following subparagraph shall be added to paragraph 2:

‘Member States may however authorize manufacturers to startthe clinical investigations in question before the expiry of the 60-day period, provided that the Ethical Committee concerned hasdelivered a favourable opinion with respect to the investigationprogramme in question.’,

— the following paragraph shall be inserted:

‘2a. The authorization referred to in the second subparagraphof paragraph 2 may be subject to approval by the competentauthority.’;

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5. the following is added to Article 14:

‘In the event of a decision as referred to in the previous paragraphthe manufacturer, or his authorized representative established in theCommunity, shall have an opportunity to put forward his viewpointin advance, unless such consultation is not possible because of theurgency of the measures to be taken.’

Article 22

Implementation, transitional provisions

1. Member States shall adopt and publish the laws, regulations andadministrative provisions necessary to comply with this Directive notlater than 1 July 1994. They shall immediately inform the Commissionthereof.

The Standing Committee referred to in Article 7 may assume its tasksfrom the date of notification (1) of this Directive. The Member Statesmay take the measures referred to in Article 16 on notification of thisDirective.

When Member States adopt these provisions, these shall contain areference to this Directive or shall be accompanied by such areference at the time of their official publication. The procedure forsuch reference shall be adopted by Member States.

Member States shall apply these provisions with effect from 1 January1995.

2. Member States shall communicate to the Commission the texts ofthe provisions of national law which they adopt in the field covered bythis Directive.

3. Member States shall take the necessary action to ensure that thenotified bodies which are responsible pursuant to Article 11 (1) to (5)for conformity assessment take account of any relevant informationregarding the characteristics and performance of such devices,including in particular the results of any relevant tests and verificationalready carried out under pre-existing national law, regulations oradministrative provisions in respect of such devices.

▼M14. Member States shall accept:

— devices which conform to the rules in force in their territory on 31December 1994 being placed on the market during a period of fiveyears following the adoption of this Directive, and

— the aforementioned devices being put into service until 30 June2001 at the latest.

▼BIn the case of devices which have been subjected to EEC patternapproval in accordance with Directive 76/764/EEC, Member Statesshall accept their being placed on the market and put into serviceduring the period up to 30 June 2004.

Article 23

This Directive is addressed to the Member States.

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(1) This Directive was notified to the Member States on 29 June 1993.

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ANNEX I

ESSENTIAL REQUIREMENTS

I. GENERAL REQUIREMENTS

▼M51. The devices must be designed and manufactured in such a way that,

when used under the conditions and for the purposes intended, theywill not compromise the clinical condition or the safety of patients, orthe safety and health of users or, where applicable, other persons,provided that any risks which may be associated with their intendeduse constitute acceptable risks when weighed against the benefits to thepatient and are compatible with a high level of protection of health andsafety.

This shall include:

— reducing, as far as possible, the risk of use error due to theergonomic features of the device and the environment in whichthe device is intended to be used (design for patient safety), and

— consideration of the technical knowledge, experience, education andtraining and where applicable the medical and physical conditionsof intended users (design for lay, professional, disabled or otherusers).

▼B2. The solutions adopted by the manufacturer for the design and

construction of the devices must conform to safety principles, takingaccount of the generally acknowledged state of the art.

In selecting the most appropriate solutions, the manufacturer mustapply the following principles in the following order:

— eliminate or reduce risks as far as possible (inherently safe designand construction),

— where appropriate take adequate protection measures includingalarms if necessary, in relation to risks that cannot be eliminated,

— inform users of the residual risks due to any shortcomings of theprotection measures adopted.

3. The devices must achieve the performances intended by the manu-facturer and be designed, manufactured and packaged in such a waythat they are suitable for one or more of the functions referred to inArticle 1 (2) (a), as specified by the manufacturer.

4. The characteristics and performances referred to in Sections 1, 2 and 3must not be adversely affected to such a degree that the clinicalconditions and safety of the patients and, where applicable, of otherpersons are compromised during the lifetime of the device as indicatedby the manufacturer, when the device is subjected to the stresses whichcan occur during normal conditions of use.

5. The devices must be designed, manufactured and packed in such a waythat their characteristics and performances during their intended usewill not be adversely affected during transport and storage takingaccount of the instructions and information provided by the manu-facturer.

6. Any undesirable side-effect must constitute an acceptable risk whenweighed against the performances intended.

▼M56a. Demonstration of conformity with the essential requirements must

include a clinical evaluation in accordance with Annex X.

▼BII. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

7. Chemical, physical and biological properties

7.1. The devices must be designed and manufactured in such a way as toguarantee the characteristics and performances referred to in Section Ion the ‘General requirements’. Particular attention must be paid to:

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— the choice of materials used, particularly as regards toxicity and,where appropriate, flammability,

— the compatibility between the materials used and biological tissues,cells and body fluids, taking account of the intended purpose of thedevice,

▼M5— where appropriate, the results of biophysical or modelling research

whose validity has been demonstrated beforehand.

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7.2. The devices must be designed, manufactured and packed in such a wayas to minimize the risk posed by contaminants and residues to thepersons involved in the transport, storage and use of the devices andto the patients, taking account of the intended purpose of the product.Particular attention must be paid to the tissues exposed and to theduration and frequency of exposure.

7.3. The devices must be designed and manufactured in such a way thatthey can be used safely with the materials, substances and gases withwhich they enter into contact during their normal use or during routineprocedures; if the devices are intended to administer medicinal productsthey must be designed and manufactured in such a way as to becompatible with the medicinal products concerned according to theprovisions and restrictions governing these products and that theirperformance is maintained in accordance with the intended use.

▼M57.4. Where a device incorporates, as an integral part, a substance which, if

used separately, may be considered to be a medicinal product asdefined in Article 1 of Directive 2001/83/EC and which is liable toact upon the body with action ancillary to that of the device, thequality, safety and usefulness of the substance must be verified byanalogy with the methods specified in Annex I to Directive 2001/83/EC.

For the substances referred to in the first paragraph, the notified bodyshall, having verified the usefulness of the substance as part of themedical device and taking account of the intended purpose of thedevice, seek a scientific opinion from one of the competent authoritiesdesignated by the Member States or the European Medicines Agency(EMEA) acting particularly through its committee in accordance withRegulation (EC) No 726/2004 (1) on the quality and safety of thesubstance including the clinical benefit/risk profile of the incorporationof the substance into the device. When issuing its opinion, thecompetent authority or the EMEA shall take into account the manu-facturing process and the data related to the usefulness of incorporationof the substance into the device as determined by the notified body.

Where a device incorporates, as an integral part, a human blood deri-vative, the notified body shall, having verified the usefulness of thesubstance as part of the medical device and taking into account theintended purpose of the device, seek a scientific opinion from theEMEA, acting particularly through its committee, on the quality andsafety of the substance including the clinical benefit/risk profile of theincorporation of the human blood derivative into the device. Whenissuing its opinion, the EMEA shall take into account the manufac-turing process and the data related to the usefulness of incorporation ofthe substance into the device as determined by the notified body.

Where changes are made to an ancillary substance incorporated in adevice, in particular related to its manufacturing process, the notifiedbody shall be informed of the changes and shall consult the relevantmedicines competent authority (i.e. the one involved in the initialconsultation), in order to confirm that the quality and safety of theancillary substance are maintained. The competent authority shalltake into account the data related to the usefulness of incorporationof the substance into the device as determined by the notified body, in

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(1) Regulation (EC) No 726/2004 of the European Parliament and of the Council of31 March 2004 laying down Community procedures for the authorisation and super-vision of medicinal products for human and veterinary use and establishing a EuropeanMedicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation as last amended by Regu-lation (EC) No 1901/2006.

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order to ensure that the changes have no negative impact on the estab-lished benefit/risk profile of the addition of the substance in themedical device.

When the relevant medicines competent authority (i.e. the one involvedin the initial consultation) has obtained information on the ancillarysubstance, which could have an impact on the established benefit/riskprofile of the addition of the substance in the medical device, it shallprovide the notified body with advice, whether this information has animpact on the established benefit/risk profile of the addition of thesubstance in the medical device or not. The notified body shall takethe updated scientific opinion into account in reconsidering itsassessment of the conformity assessment procedure.

7.5. The devices must be designed and manufactured in such a way as toreduce to a minimum the risks posed by substances leaking from thedevice. Special attention shall be given to substances which are carci-nogenic, mutagenic or toxic to reproduction, in accordance withAnnex I to Council Directive 67/548/EEC of 27 June 1967 on theapproximation of laws, regulations and administrative provisionsrelating to the classification, packaging and labelling of dangeroussubstances (1).

If parts of a device (or a device itself) intended to administer and/orremove medicines, body liquids or other substances to or from thebody, or devices intended for transport and storage of such bodyfluids or substances, contain phthalates which are classified as carci-nogenic, mutagenic or toxic to reproduction, of category 1 or 2, inaccordance with Annex I to Directive 67/548/EEC, these devicesmust be labelled on the device itself and/or on the packaging foreach unit or, where appropriate, on the sales packaging as a devicecontaining phthalates.

If the intended use of such devices includes treatment of children ortreatment of pregnant or nursing women, the manufacturer mustprovide a specific justification for the use of these substances withregard to compliance with the essential requirements, in particular ofthis paragraph, within the technical documentation and, within theinstructions for use, information on residual risks for these patientgroups and, if applicable, on appropriate precautionary measures.

▼B7.6. Devices must be designed and manufactured in such a way as to

reduce, as much as possible, risks posed by the unintentional ingressof substances into the device taking into account the device and thenature of the environment in which it is intended to be used.

8. Infection and microbial contamination

8.1. The devices and manufacturing processes must be designed in such away as to eliminate or reduce as far as possible the risk of infection tothe patient, user and third parties. The design must allow easy handlingand, where necessary, minimize contamination of the device by thepatient or vice versa during use.

8.2. Tissues of animal origin must originate from animals that have beensubjected to veterinary controls and surveillance adapted to theintended use of the tissues.

Notified bodies shall retain information on the geographical origin ofthe animals.

Processing, preservation, testing and handling of tissues, cells andsubstances of animal origin must be carried out so as to provideoptimal security. In particular safety with regard to viruses and other►M5 transmissible ◄ agents must be addressed by implementationof validated methods of elimination or viral inactivation in the courseof the manufacturing process.

8.3. Devices delivered in a sterile state must be designed, manufactured andpacked in a non-reusable pack and/or according to appropriateprocedures to ensure that they are sterile when placed on the marketand remain sterile, under the storage and transport conditions laiddown, until the protective packaging is damaged or opened.

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(1) OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of theEuropean Parliament and of the Council (OJ L 396, 30.12.2006, p. 850).

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8.4. Devices delivered in a sterile state must have been manufactured andsterilized by an appropriate, validated method.

8.5. Devices intended to be sterilized must be manufactured in appropriatelycontrolled (e. g. environmental) conditions.

8.6. Packaging systems for non-sterile devices must keep the productwithout deterioration at the level of cleanliness stipulated and, if thedevices are to be sterilized prior to use, minimize the risk of microbialcontamination; the packaging system must be suitable taking account ofthe method of sterilization indicated by the manufacturer.

8.7. The packaging and/or label of the device must distinguish betweenidentical or similar products sold in both sterile and non-sterilecondition.

9. Construction and environmental properties

9.1. If the device is intended for use in combination with other devices orequipment, the whole combination, including the connection systemmust be safe and must not impair the specified performances of thedevices. Any restrictions on use must be indicated on the label or in theinstructions for use.

9.2. Devices must be designed and manufactured in such a way as toremove or minimize as far as is possible:

— the risk of injury, in connection with their physical features,including the volume/pressure ratio, dimensional and where appro-priate ergonomic features,

— risks connected with reasonably foreseeable environmentalconditions, such as magnetic fields, external electrical influences,electrostatic discharge, pressure, temperature or variations inpressure and acceleration,

— the risks of reciprocal interference with other devices normally usedin the investigations or for the treatment given,

— risks arising where maintenance or calibration are not possible (aswith implants), from ageing of materials used or loss of accuracy ofany measuring or control mechanism.

9.3. Devices must be designed and manufactured in such a way as tominimize the risks of fire or explosion during normal use and insingle fault condition. Particular attention must be paid to deviceswhose intended use includes exposure to flammable substances or tosubstances which could cause combustion.

10. Devices with a measuring function

10.1. Devices with a measuring function must be designed and manufacturedin such a way as to provide sufficient accuracy and stability withinappropriate limits of accuracy and taking account of the intendedpurpose of the device. The limits of accuracy must be indicated bythe manufacturer.

10.2. The measurement, monitoring and display scale must be designed inline with ergonomic principles, taking account of the intended purposeof the device.

10.3. The measurements made by devices with a measuring function must beexpressed in legal units conforming to the provisions of CouncilDirective 80/181/EEC (1).

11. Protection against radiation

11.1. General

11.1.1. Devices shall be designed and manufactured in such a way thatexposure of patients, users and other persons to radiation shall bereduced as far as possible compatible with the intended purpose,whilst not restricting the application of appropriate specified levelsfor therapeutic and diagnostic purposes.

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(1) OJ No L 39, 15.2.1980, p. 40. Directive as last amended by Directive 89/617/EEC (OJNo L 357, 7.12.1989, p. 28).

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11.2. Intended radiation

11.2.1. Where devices are designed to emit hazardous levels of radiationnecessary for a specific medical purpose the benefit of which isconsidered to outweigh the risks inherent in the emission, it must bepossible for the user to control the emissions. Such devices shall bedesigned and manufactured to ensure reproducibility and tolerance ofrelevant variable parameters.

11.2.2. Where devices are intended to emit potentially hazardous, visible and/or invisible radiation, they must be fitted, where practicable, with visualdisplays and/or audible warnings of such emissions.

11.3. Unintended radiation

11.3.1. Devices shall be designed and manufactured in such a way thatexposure of patients, users and other persons to the emission of unin-tended, stray or scattered radiation is reduced as far as possible.

11.4. Instructions

11.4.1. The operating instructions for devices emitting radiation must givedetailed information as to the nature of the emitted radiation, meansof protecting the patient and the user and on ways of avoiding misuseand of eliminating the risks inherent in installation.

11.5. Ionizing radiation

11.5.1. Devices intended to emit ionizing radiation must be designed andmanufactured in such a way as to ensure that, where practicable, thequantity, geometry and quality of radiation emitted can be varied andcontrolled taking into account the intended use.

11.5.2. Devices emitting ionizing radiation intended for diagnostic radiologyshall be designed and manufactured in such a way as to achieve appro-priate image and/or output quality for the intended medical purposewhilst minimizing radiation exposure of the patient and user.

11.5.3. Devices emitting ionizing radiation, intended for therapeutic radiologyshall be designed and manufactured in such a way as to enable reliablemonitoring and control of the delivered dose, the beam type and energyand where appropriate the quality of radiation.

12. Requirements for medical devices connected to or equipped with anenergy source

12.1. Devices incorporating electronic programmable systems must bedesigned to ensure the repeatability, reliability and performance ofthese systems according to the intended use. In the event of a singlefault condition (in the system) appropriate means should be adopted toeliminate or reduce as far as possible consequent risks.

▼M512.1a For devices which incorporate software or which are medical software

in themselves, the software must be validated according to the state ofthe art taking into account the principles of development lifecycle, riskmanagement, validation and verification.

▼B12.2. Devices where the safety of the patients depends on an internal power

supply must be equipped with a means of determining the state of thepower supply.

12.3. Devices where the safety of the patients depends on an external powersupply must include an alarm system to signal any power failure.

12.4. Devices intended to monitor one or more clinical parameters of apatient must be equipped with appropriate alarm systems to alert theuser of situations which could lead to death or severe deterioration ofthe patient's state of health.

12.5. Devices must be designed and manufactured in such a way as tominimize the risks of creating electromagnetic fields which couldimpair the operation of other devices or equipment in the usual envir-onment.

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12.6. Protection against electrical risks

Devices must be designed and manufactured in such a way as to avoid,as far as possible, the risk of accidental electric shocks during normaluse and in single fault condition, provided the devices are installedcorrectly.

12.7. Protection against mechanical and thermal risks

12.7.1. Devices must be designed and manufactured in such a way as toprotect the patient and user against mechanical risks connected with,for example, resistance, stability and moving parts.

12.7.2. Devices must be designed and manufactured in such a way as to reduceto the lowest possible level the risks arising from vibration generatedby the devices, taking account of technical progress and of the meansavailable for limiting vibrations, particularly at source, unless thevibrations are part of the specified performance.

12.7.3. Devices must be designed and manufactured in such a way as to reduceto the lowest possible level the risks arising from the noise emitted,taking account of technical progress and of the means available toreduce noise, particularly at source, unless the noise emitted is partof the specified performance.

12.7.4. Terminals and connectors to the electricity, gas or hydraulic andpneumatic energy supplies which the user has to handle must bedesigned and constructed in such a way as to minimize all possiblerisks.

12.7.5. Accessible parts of the devices (excluding the parts or areas intended tosupply heat or reach given temperatures) and their surroundings mustnot attain potentially dangerous temperatures under normal use.

12.8. Protection against the risks posed to the patient by energy supplies orsubstances

12.8.1. Devices for supplying the patient with energy or substances must bedesigned and constructed in such a way that the flow-rate can be setand maintained accurately enough to guarantee the safety of the patientand of the user.

12.8.2. Devices must be fitted with the means of preventing and/or indicatingany inadequacies in the flow-rate which could pose a danger.

Devices must incorporate suitable means to prevent, as far as possible,the accidental release of dangerous levels of energy from an energyand/or substance source.

12.9. The function of the controls and indicators must be clearly specified onthe devices.

Where a device bears instructions required for its operation or indicatesoperating or adjustment parameters by means of a visual system, suchinformation must be understandable to the user and, as appropriate, thepatient.

13. Information supplied by the manufacturer

▼M513.1. Each device must be accompanied by the information needed to use it

safely and properly, taking account of the training and knowledge ofthe potential users, and to identify the manufacturer.

▼BThis information comprises the details on the label and the data in theinstructions for use.

As far as practicable and appropriate, the information needed to use thedevice safely must be set out on the device itself and/or on thepackaging for each unit or, where appropriate, on the salespackaging. If individual packaging of each unit is not practicable, theinformation must be set out in the leaflet supplied with one or moredevices.

Instructions for use must be included in the packaging for every device.By way of exception, no such instructions for use are needed fordevices in Class I or IIa if they can be used safely without any suchinstructions.

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13.2. Where appropriate, this information should take the form of symbols.Any symbol or identification colour used must conform to theharmonized standards. In areas for which no standards exist, thesymbols and colours must be described in the documentationsupplied with the device.

13.3. The label must bear the following particulars:

▼M5(a) the name or trade name and address of the manufacturer. For

devices imported into the Community, in view of their distributionin the Community, the label, or the outer packaging, orinstructions for use, shall contain in addition the name andaddress of the authorised representative where the manufacturerdoes not have a registered place of business in the Community;

(b) the details strictly necessary to identify the device and the contentsof the packaging especially for the users;

▼B(c) where appropriate, the word ‘STERILE’;

(d) where appropriate, the batch code, preceded by the word ‘LOT’,or the serial number;

(e) where appropriate, an indication of the date by which the deviceshould be used, in safety, expressed as the year and month;

▼M5(f) where appropriate, an indication that the device is for single use. A

manufacturer's indication of single use must be consistent acrossthe Community;

▼B(g) if the device is costum-made, the words ‘custom-made device’;

(h) if the device is intended for clinical investigations, the words‘exclusively for clinical investigations’;

(i) any special storage and/or handling conditions;

(j) any special operating instructions;

(k) any warnings and/or precautions to take;

(l) year of manufacture for active devices other than those covered by(e). This indication may be included in the batch or serial number;

(m) where applicable, method of sterilization;

▼M2(n) in the case of a device within the meaning of Article 1(4a), an

indication that the device contains a human blood derivative.

▼B13.4. If the intended purpose of the device is not obvious to the user, the

manufacturer must clearly state it on the label and in the instructionsfor use.

13.5. Wherever reasonable and practicable, the devices and detachablecomponents must be identified, where appropriate in terms ofbatches, to allow all appropriate action to detect any potential riskposed by the devices and detachable components.

13.6. Where appropriate, the instructions for use must contain the followingparticulars:

(a) the details referred to in Section 13.3, with the exception of (d) and(e);

(b) the performances referred to in Section 3 and any undesirable side-effects;

(c) if the device must be installed with or connected to other medicaldevices or equipment in order to operate as required for itsintended purpose, sufficient details of its characteristics toidentify the correct devices or equipment to use in order toobtain a safe combination;

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(d) all the information needed to verify whether the device is properlyinstalled and can operate correctly and safely, plus details of thenature and frequency of the maintenance and calibration needed toensure that the devices operate properly and safely at all times;

(e) where appropriate, information to avoid certain risks in connectionwith implantation of the device;

(f) information regarding the risks of reciprocal interference posed bythe presence of the device during specific investigations ortreatment;

(g) the necessary instructions in the event of damage to the sterilepackaging and, where appropriate, details of appropriate methodsof resterilization;

(h) if the device is reusable, information on the appropriate processesto allow reuse, including cleaning, disinfection, packaging and,where appropriate, the method of sterilization of the device to beresterilized, and any restriction on the number of reuses.

Where devices are supplied with the intention that they be ster-ilized before use, the instructions for cleaning and sterilization mustbe such that, if correctly followed, the device will still comply withthe requirements in Section I.

▼M5If the device bears an indication that the device is for single use,information on known characteristics and technical factors knownto the manufacturer that could pose a risk if the device were to bere-used. If in accordance with Section 13.1 no instructions for useare needed, the information must be made available to the userupon request;

▼B(i) details of any further treatment or handling needed before the

device can be used (for example, sterilization, final assembly, etc.);

(j) in the case of devices emitting radiation for medical purposes,details of the nature, type, intensity and distribution of thisradiation.

The instructions for use must also include details allowing the medicalstaff to brief the patient on any contra-indications and any precautionsto be taken. These details should cover in particular:

(k) precautions to be taken in the event of changes in the performanceof the device;

(l) precautions to be taken as regards exposure, in reasonably fore-seeable environmental conditions, to magnetic fields, external elec-trical influences, electrostatic discharge, pressure or variations inpressure, acceleration, thermal ignition sources, etc.;

(m) adequate information regarding the medicinal product or productswhich the device in question is designed to administer, includingany limitations in the choice of substances to be delivered;

(n) precautions to be taken against any special, unusual risks related tothe disposal of the device;

▼M5(o) medicinal substances, or human blood derivatives incorporated

into the device as an integral part in accordance with Section 7.4;

▼B(p) degree of accuracy claimed for devices with a measuring function;

▼M5(q) date of issue or the latest revision of the instructions for use.

__________

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ANNEX II

EC DECLARATION OF CONFORMITY

(Full quality assurance system)

1. The manufacturer must ensure application of the quality system approvedfor the design, manufacture and final inspection of the products concerned,as specified in Section 3 and is subject to audit as laid down in Sections 3.3and 4 and to Community surveillance as specified in Section 5.

▼M52. The EC declaration of conformity is the procedure whereby the manu-

facturer who fulfils the obligations imposed by Section 1 ensures anddeclares that the products concerned meet the provisions of this Directivewhich apply to them.

The manufacturer must affix the CE marking in accordance with Article 17and draw up a written declaration of conformity. This declaration mustcover one or more medical devices manufactured, clearly identified bymeans of product name, product code or other unambiguous referenceand must be kept by the manufacturer.

▼B3. Quality system

3.1. The manufacturer must lodge an application for assessment of his qualitysystem with a notified body.

The application must include:

— the name and address of the manufacturer and any additional manufac-turing site covered by the quality system,

— all the relevant information on the product or product category coveredby the procedure,

— a written declaration that no application has been lodged with any othernotified body for the same product-related quality system,

— the documentation on the quality system,

— an undertaking by the manufacturer to fulfil the obligations imposed bythe quality system approved,

— an undertaking by the manufacturer to keep the approved qualitysystem adequate and efficacious,

— ►M5 an undertaking by the manufacturer to institute and keep up todate a systematic procedure to review experience gained from devicesin the post-production phase, including the provisions referred to inAnnex X, and to implement appropriate means to apply anynecessary corrective action. This undertaking must include an obligationfor the manufacturer to notify the competent authorities of the followingincidents immediately on learning of them: ◄

(i) any malfunction or deterioration in the characteristics and/orperformance of a device, as well as any inadequacy in theinstructions for use which might lead to or might have led to thedeath of a patient or user or to a serious deterioration in his state ofhealth;

(ii) any technical or medical reason connected with the characteristicsor performance of a device leading for the reasons referred to insubparagraph (i) to systematic recall of devices of the same type bythe manufacturer.

3.2. Application of the quality system must ensure that the products conform tothe provisions of this Directive which apply to them at every stage, fromdesign to final inspection. All the elements, requirements and provisionsadopted by the manufacturer for his quality system must be documented ina systematic and orderly manner in the form of written policies andprocedures such as quality programmes, quality plans, quality manualsand quality records.

▼M5It shall include in particular the corresponding documentation, data andrecords arising from the procedures referred to in point (c).

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It shall include in particular an adequate description of:

(a) the manufacturer's quality objectives;

(b) the organization of the business and in particular:

— the organizational structures, the responsibilities of the managerialstaff and their organizational authority where quality of design andmanufacture of the products is concerned,

— the methods of monitoring the efficient operation of the qualitysystem and in particular its ability to achieve the desired qualityof design and of product, including control of products which failto conform,

▼M5— where the design, manufacture and/or final inspection and testing of

the products, or elements thereof, is carried out by a third party, themethods of monitoring the efficient operation of the quality systemand in particular the type and extent of control applied to the thirdparty;

(c) the procedures for monitoring and verifying the design of the products,including the corresponding documentation, and in particular:

— a general description of the product, including any variants planned,and its intended use(s),

— the design specifications, including the standards which will beapplied and the results of the risk analysis, and also a descriptionof the solutions adopted to fulfil the essential requirements whichapply to the products if the standards referred to in Article 5 are notapplied in full,

— the techniques used to control and verify the design and theprocesses and systematic measures which will be used when theproducts are being designed,

— if the device is to be connected to other device(s) in order tooperate as intended, proof must be provided that it conforms tothe essential requirements when connected to any such device(s)having the characteristics specified by the manufacturer,

— a statement indicating whether or not the device incorporates, as anintegral part, a substance or a human blood derivative referred to insection 7.4 of Annex I and the data on the tests conducted in thisconnection required to assess the safety, quality and usefulness ofthat substance or human blood derivative, taking account of theintended purpose of the device,

— a statement indicating whether or not the device is manufacturedutilising tissues of animal origin as referred to in CommissionDirective 2003/32/EC (1),

— the solutions adopted as referred to in Annex I, Chapter I,Section 2,

— the pre-clinical evaluation,

— the clinical evaluation referred to in Annex X,

— the draft label and, where appropriate, instructions for use.

▼B(d) the inspection and quality assurance techniques at the manufacturing

stage and in particular:

— the processes and procedures which will be used, particularly asregards sterilization, purchasing and the relevant documents,

— the product identification procedures drawn up and kept up to datefrom drawings, specifications or other relevant documents at everystage of manufacture;

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(1) Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specificationsas regards the requirements laid down in Council Directive 93/42/EEC with respect tomedical devices manufactured utilising tissues of animal origin (OJ L 105, 26.4.2003,p. 18).

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(e) the appropriate tests and trials which will be carried out before, duringand after manufacture, the frequency with which they will take place,and the test equipment used; it must be possible to trace back thecalibration of the test equipment adequately.

3.3. The notified body must audit the quality system to determine whether itmeets the requirements referred to in Section 3.2. It must presume thatquality systems which implement the relevant harmonized standardsconform to these requirements.

▼M5The assessment team must include at least one member with pastexperience of assessments of the technology concerned. The assessmentprocedure must include an assessment, on a representative basis, of thedocumentation of the design of the product(s) concerned, an inspectionon the manufacturer's premises and, in duly substantiated cases, on thepremises of the manufacturer's suppliers and/or subcontractors to inspectthe manufacturing processes.

▼BThe decision is notified to the manufacturer. It must contain theconclusions of the inspection and a reasoned assessment.

3.4. The manufacturer must inform the notified body which approved thequality system of any plan for substantial changes to the quality systemor the product-range covered. The notified body must assess the changesproposed and verify whether after these changes the quality system stillmeets the requirements referred to in Section 3.2. It must notify the manu-facturer of its decision. This decision must contain the conclusions of theinspection and a reasoned assessment.

4. Examination of the design of the product

4.1. In addition to the obligations imposed by Section 3, the manufacturer mustlodge with the notified body an application for examination of the designdossier relating to the product which he plans to manufacture and whichfalls into the category referred to in Section 3.1.

4.2. The application must describe the design, manufacture and performances ofthe product in question. It must include the documents needed to assesswhether the product conforms to the requirements of this Directive, asreferred to in Section 3.2 (c).

4.3. The notified body must examine the application and, if the productconforms to the relevant provisions of this Directive, issue the applicationwith an EC design-examination certificate. The notified body may requirethe application to be completed by further tests or proof to allowassessment of conformity with the requirements of the Directive. The certi-ficate must contain the conclusions of the examination, the conditions ofvalidity, the data needed for identification of the approved design, whereappropriate, a description of the intended purpose of the product.

▼M5In the case of devices referred to in Annex I, Section 7.4, secondparagraph, the notified body shall, as regards the aspects referred to inthat section, consult one of the competent authorities designated by theMember States in accordance with Directive 2001/83/EC or the EMEAbefore taking a decision. The opinion of the competent national authorityor the EMEA must be drawn up within 210 days after receipt of validdocumentation. The scientific opinion of the competent national authorityor the EMEA must be included in the documentation concerning thedevice. The notified body will give due consideration to the viewsexpressed in this consultation when making its decision. It will conveyits final decision to the competent body concerned.

In the case of devices referred to in Annex I, Section 7.4, third paragraph,the scientific opinion of the EMEA must be included in the documentationconcerning the device. The opinion of the EMEA must be drawn up within210 days after receipt of valid documentation. The notified body will givedue consideration to the opinion of the EMEA when making its decision.The notified body may not deliver the certificate if the EMEA's scientificopinion is unfavourable. It will convey its final decision to the EMEA.

In the case of devices manufactured utilising tissues of animal origin asreferred to in Directive 2003/32/EC, the notified body must follow theprocedures referred to in that Directive.

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4.4. Changes to the approved design must receive further approval from thenotified body which issued the EC design-examination certificate whereverthe changes could affect conformity with the essential requirements of theDirective or with the conditions prescribed for use of the product. Theapplicant shall inform the notified body which issued the EC design-exam-ination certificate of any such changes made to the approved design. Thisadditional approval must take the form of a supplement to the EC design-examination certificate.

5. Surveillance

5.1. The aim of surveillance is to ensure that the manufacturer duly fulfils theobligations imposed by the approved quality system.

5.2. The manufacturer must authorize the notified body to carry out all thenecessary inspections and supply it with all relevant information, inparticular:


▼M5— the data stipulated in the part of the quality system relating to design,

such as the results of analyses, calculations, tests, the solutions adoptedas referred to in Annex I, Chapter I, Section 2, pre-clinical and clinicalevaluation, post-market clinical follow-up plan and the results of thepost-market clinical follow-up, if applicable, etc.,

▼B— the data stipulated in the part of the quality system relating to manu-

facture, such as inspection reports and test data, calibration data, quali-fication reports of the personnel concerned, etc.

5.3. The notified body must periodically carry out appropriate inspections andassessments to make sure that the manufacturer applies the approvedquality system and must supply the manufacturer with an assessment report.

5.4. In addition, the notified body may pay unannounced visits to the manu-facturer. At the time of such visits, the notified body may, where necessary,carry out or ask for tests in order to check that the quality system isworking properly. It must provide the manufacturer with an inspectionreport and, if a test has been carried out, with a test report.

6. Administrative provisions

6.1. ►M5 The manufacturer or his authorised representative must, for a periodending at least five years, and in the case of implantable devices at least 15years, after the last product has been manufactured, keep at the disposal ofthe national authorities: ◄

— the declaration of conformity,

— the documentation referred to in the fourth indent of Section 3.1►M5 and in particular the documentation, data and records referredto in the second paragraph of Section 3.2 ◄,

— the changes referred to in Section 3.4,

— the documentation referred to in Section 4.2, and

— the decisions and reports from the notified body as referred to inSections 3.3, 4.3, 4.4, 5.3 and 5.4.

▼M1__________

▼M5__________

7. Application to devices in Classes IIa and IIb.

7.1. In line with Article 11(2) and (3), this Annex may apply to products inClasses IIa and IIb. Section 4, however, does not apply.

7.2. For devices in Class IIa the notified body shall assess, as part of theassessment in Section 3.3, the technical documentation as described inSection 3.2(c) for at least one representative sample for each device subca-tegory for compliance with the provisions of this Directive.

7.3. For devices in Class IIb the notified body shall assess, as part of theassessment in Section 3.3, the technical documentation as described in

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▼M5

Section 3.2(c) for at least one representative sample for each generic devicegroup for compliance with the provisions of this Directive.

7.4. In choosing representative sample(s) the notified body shall take intoaccount the novelty of the technology, similarities in design, technology,manufacturing and sterilisation methods, the intended use and the results ofany previous relevant assessments (e.g. with regard to physical, chemical orbiological properties) that have been carried out in accordance with thisDirective. The notified body shall document and keep available to thecompetent authority its rationale for the sample(s) taken.

7.5. Further samples shall be assessed by the notified body as part of thesurveillance assessment referred to in Section 5.

▼M28. Application to the devices referred to Article 1(4a)

Upon completing the manufacture of each batch of devices referred to inArticle 1(4a), the manufacturer shall inform the notified body of the releaseof the batch of devices and send to it the official certificate concerning therelease of the batch of human blood derivative used in the device, issued bya State laboratory or a laboratory designated for that purpose by a MemberState in accordance with ►M5 Article 114(2) of Directive 2001/83/EC ◄.

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ANNEX III

EC TYPE-EXAMINATION

1. EC type-examination is the procedure whereby a notified body ascertainsand certifies that a representative sample of the production covered fulfilsthe relevant provisions of this Directive.

2. The application includes:

— the name and address of the manufacturer and the name and address ofthe authorized representative if the application is lodged by the repre-sentative,

— the documentation described in Section 3 needed to assess theconformity of the representative sample of the production in question,hereinafter referred to as the ‘type’, with the requirements of thisDirective. The applicant must make a ‘type’ available to the notifiedbody. The notified body may request other samples as necessary,

— a written declaration that no application has been lodged with any othernotified body for the same type.

▼M53. The documentation must allow an understanding of the design, the manu-

facture and the performances of the product and must contain the followingitems in particular:

— a general description of the type, including any variants planned, and itsintended use(s),

— design drawings, methods of manufacture envisaged, in particular asregards sterilisation, and diagrams of components, sub-assemblies,circuits, etc.,

— the descriptions and explanations necessary to understand the above-mentioned drawings and diagrams and the operation of the product,

— a list of the standards referred to in Article 5, applied in full or in part,and descriptions of the solutions adopted to meet the essentialrequirements if the standards referred to in Article 5 have not beenapplied in full,

— the results of the design calculations, risk analysis, investigations,technical tests, etc. carried out,

— a statement indicating whether or not the device incorporates, as anintegral part, a substance, or human blood derivative, referred to inSection 7.4 of Annex I, and the data on the tests conducted in thisconnection which are required to assess the safety, quality andusefulness of that substance, or human blood derivative, takingaccount of the intended purpose of the device,

— a statement indicating whether or not the device is manufacturedutilising tissues of animal origin as referred to in Directive 2003/32/EC,

— the solutions adopted as referred to in Annex I, Chapter I, Section 2,




▼B4. The notified body must:

4.1. examine and assess the documentation and verify that the type has beenmanufactured in conformity with that documentation; it must also recordthe items designed in conformity with the applicable provisions of thestandards referred to in Article 5, as well as the items not designed onthe basis of the relevant provisions of the abovementioned standards;

4.2. carry out or arrange for the appropriate inspections and the tests necessaryto verify whether the solutions adopted by the manufacturer meet theessential requirements of this Directive if the standards referred to inArticle 5 have not been applied; if the device is to be connected to otherdevice(s) in order to operate as intended, proof must be provided that it

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▼B

conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer;

4.3. carry out or arrange for the appropriate inspections and the tests necessaryto verify whether, if the manufacturer has chosen to apply the relevantstandards, these have actually been applied;

4.4. agree with the applicant on the place where the necessary inspections andtests will be caried out.

5. If the type conforms to the provisions of this Directive, the notified bodyissues the applicant with an EC type-examination certificate. The certificatemust contain the name and address of the manufacturer, the conclusions ofthe inspection, the conditions of validity and the data needed for identifi-cation of the type approved. The relevant parts of the documentation mustbe annexed to the certificate and a copy kept by the notified body.

▼M5In the case of devices referred to in Annex I, Section 7.4, secondparagraph, the notified body shall, as regards the aspects referred to inthat section, consult one of the authorities designated by the MemberStates in accordance with Directive 2001/83/EC or the EMEA beforetaking a decision. The opinion of the competent national authority or theEMEA must be drawn up within 210 days after receipt of valid documen-tation. The scientific opinion of the competent national authority or theEMEA must be included in the documentation concerning the device.The notified body will give due consideration to the views expressed inthis consultation when making its decision. It will convey its final decisionto the competent body concerned.

In the case of devices referred to in Annex I, Section 7.4, third paragraph,the scientific opinion of the EMEA must be included in the documentationconcerning the device. The opinion of the EMEA must be drawn up within210 days after receipt of valid documentation. The notified body will givedue consideration to the opinion of the EMEA when making its decision.The notified body may not deliver the certificate if the EMEA's scientificopinion is unfavourable. It will convey its final decision to the EMEA.

In the case of devices manufactured utilising tissues of animal origin asreferred to in Directive 2003/32/EC, the notified body must follow theprocedures referred to in that Directive.

▼B6. The applicant must inform the notified body which issued the EC type-

examination certificate of any significant change made to the approvedproduct.

Changes to the approved product must receive further approval from thenotified body which issued the EC type-examination certificate whereverthe changes may affect conformity with the essential requirements or withthe conditions prescribed for use of the product. This new approval must,where appropriate, take the form of a supplement to the initial EC type-examination certificate.


▼M1__________

▼B7.2. Other notified bodies may obtain a copy of the EC type-examination certi-

ficates and/or the supplements thereto. The Annexes to the certificates mustbe made available to other notified bodies on reasoned application, after themanufacturer has been informed.

▼M57.3. The manufacturer or his authorised representative must keep with the

technical documentation copies of EC type-examination certificates andtheir additions for a period ending at least five years after the last devicehas been manufactured. In the case of implantable devices, the period shallbe at least 15 years after the last product has been manufactured.

__________

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▼B

ANNEX IV

EC VERIFICATION

1. EC verification is the procedure whereby the manufacturer or his authorizedrepresentative ►M5 __________ ◄ ensures and declares that theproducts which have been subject to the procedure set out in Section 4conform to the type described in the EC type-examination certificate andmeet the requirements of this Directive which apply to them.

2. The manufacturer must take all the measures necessary to ensure that themanufacturing process produces products which conform to the typedescribed in the EC type-examination certificate and to the requirementsof the Directive which apply to them. Before the start of manufacture, themanufacturer must prepare documents defining the manufacturing process,in particular as regards sterilization where necessary, together with all theroutine, pre-established provisions to be implemented to ensure homo-geneous production and, where appropriate, conformity of the productswith the type described in the EC type-examination certificate and withthe requirements of this Directive which apply to them. The manufacturermust affix the CE marking in accordance with Article 17 and draw up adeclaration of conformity.

In addition, for products placed on the market in sterile condition, and onlyfor those aspects of the manufacturing process designed to secure andmaintain sterility, the manufacturer must apply the provisions of AnnexV, Sections 3 and 4.

▼M53. The manufacturer must undertake to institute and keep up to date a

systematic procedure to review experience gained from devices in thepost-production phase, including the provisions referred to in Annex X,and to implement appropriate means to apply any necessary correctiveaction. This undertaking must include an obligation for the manufacturerto notify the competent authorities of the following incidents immediatelyon learning of them:

▼B(i) any malfunction or deterioration in the characteristics and/or

performance of a device, as well as any inadequacy in the labellingor the instructions for use which might lead to or might have led to thedeath of a patient or user or to a serious deterioration in his state ofhealth;

(ii) any technical or medical reason connected with the characteristics orperformance of a device for the reasons referred to in subparagraph (i)leading to systematic recall of devices of the same type by the manu-facturer.

4. The notified body must carry out the appropriate examinations and tests inorder to verify the conformity of the product with the requirements of theDirective either by examining and testing every product as specified inSection 5 or by examining and testing products on a statistical basis asspecified in Section 6, as the manufacturer decides.

The aforementioned checks do not apply to those aspects of the manufac-turing process designed to secure sterility.

5. Verification by examination and testing of every product

5.1. Every product is examined individually and the appropriate tests defined inthe relevant standard(s) referred to in Article 5 or equivalent tests must becarried out in order to verify, where appropriate, the conformity of theproducts with the EC type described in the type-examination certificateand with the requirements of the Directive which apply to them.

5.2. The notified body must affix, or have affixed its identification number toeach approved product and must draw up a written certificate of conformityrelating to the tests carried out.

6. Statistical verification

6.1. The manufacturer must present the manufactured products in the form ofhomogeneous batches.

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▼B

6.2. A random sample is taken from each batch. The products which make upthe sample are examined individually and the appropriate tests defined inthe relevant standard(s) referred to in Article 5 or equivalent tests must becarried out to verify, where appropriate, the conformity of the products withthe type described in the EC type-examination certificate and with therequirements of the Directive which apply to them in order to determinewhether to accept or reject the batch.

▼M56.3. Statistical control of products will be based on attributes and/or variables,

entailing sampling schemes with operational characteristics which ensure ahigh level of safety and performance according to the state of the art. Thesampling schemes will be established by the harmonised standards referredto in Article 5, taking account of the specific nature of the product cate-gories in question.

▼B6.4. If the batch is accepted, the notified body affixes or has affixed its identi-

fication number to each product and draws up a written certificate ofconformity relating to the tests carried out. All products in the batchmay be put on the market except any in the sample which failed toconform.

If a batch is rejected, the competent notified body must take appropriatemeasures to prevent the batch from being placed on the market. In theevent of frequent rejection of batches, the notified body may suspend thestatistical verification.

The manufacturer may, on the responsibility of the notified body, affix thenotified body's identification number during the manufacturing process.


►M5 The manufacturer or his authorised representative must, for a periodending at least five years, and in the case of implantable devices at least 15years, after the last product has been manufactured, make available to thenational authorities: ◄


— the documentation referred to in Section 2,

— the certificates referred to in Sections 5.2 and 6.4,

— where appropriate, the type-examination certificate referred to in AnnexIII.

8. Application to devices in Class IIa

In line with Article 11 (2), this Annex may apply to products in Class IIa,subject to the following ►M5 __________ ◄:

8.1. in derogation from Sections 1 and 2, by virtue of the declaration ofconformity the manufacturer ensures and declares that the products inClass IIa are manufactured in conformity with the technical documentationreferred to in Section 3 of Annex VII and meet the requirements of thisDirective which apply to them;

8.2. in derogation from Sections 1, 2, 5 and 6, the verifications conducted bythe notified body are intended to confirm the conformity of the products inClass IIa with the technical documentation referred to in Section 3 ofAnnex VII.

▼M29. Application to devices referred to in Article 1(4a)

In the case of section 5, upon completing the manufacture of each batch ofdevices referred to in Article 1(4a), and in the case of verification undersection 6, the manufacturer shall inform the notified body of the release ofthis batch of devices and send to it the official certificate concerning therelease of the batch of human blood derivative used in the device issued bya State laboratory or a laboratory designated for that purpose by a MemberState in accordance with ►M5 Article 114(2) of Directive 2001/83/EC ◄.

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▼B

ANNEX V


(Production quality assurance)

1. The manufacturer must ensure application of the quality system approvedfor the manufacture of the products concerned and carry out the finalinspection, as specified in Section 3, and is subject to the Communitysurveillance referred to in Section 4.

▼M52. The EC declaration of conformity is the part of the procedure whereby the

manufacturer who fulfils the obligations imposed by Section 1 ensures anddeclares that the products concerned conform to the type described in theEC type-examination certificate and meet the provisions of this Directivewhich apply to them.

The manufacturer must affix the CE marking in accordance with Article 17and draw up a written declaration of conformity. This declaration mustcover one or more medical devices manufactured, clearly identified bymeans of product name, product code or other unambiguous reference,and must be kept by the manufacturer.


3.1. The manufacturer must lodge an application for assessment of his qualitysystem with a notified body.


— the name and address of the manufacturer,


— a written declaration that no application has been lodged with any othernotified body for the same products,


— an undertaking to fulfil the obligations imposed by the quality system isapproved,

— an undertaking to maintain the practicability and effectiveness of theapproved quality system,

— where appropriate, the technical documentation on the types approvedand a copy of the EC type-examination certificates,


(i) any malfunction or deterioration in the characteristics and/orperformance of a device, as well as any inadequacy in thelabelling or the instructions for use which might lead to or mighthave led to the death of a patient or user or to a serious dete-rioration in his state of health;

(ii) any technical or medical reason connected with the characteristicsor performance of a device for the reasons referred to in subpar-agraph (i) above leading to a systematic recall of devices of thesame type by the manufacturer.

3.2. Application of the quality system must ensure that the products conform tothe type described in the EC type-examination certificate.

All the elements, requirements and provisions adopted by the manufacturerfor his quality system must be documented in a systematic and orderlymanner in the form of written policy statements and procedures. Thisquality system documentation must permit uniform interpretation of the

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▼B

quality policy and procedures such as quality programmes, plans, manualsand records.

It must include in particular an adequate description of:

(a) the manufacturer's quality objectives;

(b) the organization of the business and in particular:

— the organizational structures, the responsibilities of the managerialstaff and their organizational authority where manufacture of theproducts is concerned,

— the methods of monitoring the efficient operation of the qualitysystem and in particular its ability to achieve the desired qualityof product, including control of products which fail to conform,

▼M5— where the manufacture and/or final inspection and testing of the

products, or elements thereof, are carried out by a third party, themethods of monitoring the efficient operation of the quality systemand in particular the type and extent of control applied to the thirdparty;

▼B(c) the inspection and quality assurance techniques at the manufacturing

stage and in particular:

— the processes and procedures which will be used, particularly asregards sterilization, purchasing and the relevant documents,

— the product identification procedures drawn up and kept up to datefrom drawings, specifications or other relevant documents at everystage of manufacture;

(d) the appropriate tests and trials to be carried out before, during and aftermanufacture, the frequency with which they will take place, and thetest equipment used; it must be possible adequately to trace back thecalibration of the test equipment.

3.3. The notified body must audit the quality system to determine whether itmeets the requirements referred to in Section 3.2. It must presume thatquality systems which implement the relevant harmonized standardsconform to these requirements.

The assessment team must include at least one member with pastexperience of assessments of the technology concerned. The assessmentprocedure must include an inspection on the manufacturer's premises and,in duly substantiated cases, on the premises of the manufacturer's suppliersto inspect the manufacturing processes.

The decision must be notified to the manufacturer after the final inspectionand contain the conclusions of the inspection and a reasoned assessment.

3.4. The manufacturer must inform the notified body which approved thequality system of any plan for substantial changes to the quality system.

The notified body must assess the changes proposed and verify whetherafter these changes the quality system still meets the requirements referredto in Section 3.2.

After the abovementioned information has been received the decision isnotified to the manufacturer. It must contain the conclusions of theinspection and a reasoned assessment.

4. Surveillance


4.2. The manufacturer authorizes the notified body to carry out all the necessaryinspections and must supply it with all relevant information, in particular:


▼M5— the technical documentation,

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▼B

— the data stipulated in the part of the quality system relating to manu-facture, such as inspection reports and test data, calibration data, quali-fication reports of the personnel concerned, etc.

4.3. The notified body must periodically carry out appropriate inspections andassessments to make sure that the manufacturer applies the approvedquality system and supply the manufacturer with an assessment report.

4.4. In addition, the notified body may pay unannounced visits to the manu-facturer. At the time of such visits, the notified body may, where necessary,carry out or ask for tests in order to check that the quality system isworking properly. It must provide the manufacturer with an inspectionreport and, if a test has been carried out, with a test report.


5.1. ►M5 The manufacturer or his authorised representative must, for a periodending at least five years, and in the case of implantable devices at least 15years, after the last product has been manufactured, make available to thenational authorities: ◄


— the documentation referred to in the fourth indent of Section 3.1,


— the documentation referred to in the seventh indent of Section 3.1,

— the decisions and reports from the notified body as referred to inSections 4.3 and 4.4,

— where appropriate, the type-examination certificate referred to in AnnexIII.

▼M1__________

▼M56. Application to devices in Class IIa

In line with Article 11(2), this Annex may apply to products in Class IIa,subject to the following:

6.1. By way of derogation from Sections 2, 3.1 and 3.2, by virtue of thedeclaration of conformity the manufacturer ensures and declares that theproducts in Class IIa are manufactured in conformity with the technicaldocumentation referred to in Section 3 of Annex VII and meet therequirements of this Directive which apply to them.

6.2. For devices in Class IIa the notified body shall assess, as part of theassessment in Section 3.3, the technical documentation as described inSection 3 of Annex VII for at least one representative sample for eachdevice subcategory for compliance with the provisions of this Directive.


6.4. Further samples shall be assessed by the notified body as part of thesurveillance assessment referred to in Section 4.3.

▼M27. Application to devices referred to in Article 1(4a)

Upon completing the manufacture of each batch of devices referred to inArticle 1(4a), the manufacturer shall inform the notified body of the releaseof the batch of devices and send to it the official certificate concerning therelease of the batch of human blood derivative used in the device issued bya State laboratory or a laboratory designated for that purpose by a MemberState in accordance with ►M5 Article 114(2) of Directive 2001/83/EC ◄.

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▼B

ANNEX VI


(Product quality assurance)

1. The manufacturer must ensure application of the quality system approvedfor the final inspection and testing of the product, as specified in Section 3and must be subject to the surveillance referred to in Section 4.

In addition, for products placed on the market in sterile condition, and onlyfor those aspects of the manufacturing process designed to secure andmaintain sterility, the manufacturer must apply the provisions of AnnexV, Sections 3 and 4.

▼M52. The EC declaration of conformity is the part of the procedure whereby the

manufacturer who fulfils the obligations imposed by Section 1 ensures anddeclares that the products concerned conform to the type described in theEC type-examination certificate and meet the provisions of this Directivewhich apply to them.

The manufacturer affixes the CE marking in accordance with Article 17and draws up a written declaration of conformity. This declaration mustcover one or more medical devices manufactured, clearly identified bymeans of product name, product code or other unambiguous reference,and be kept by the manufacturer. The CE marking must be accompaniedby the identification number of the notified body which performs the tasksreferred to in this Annex.


3.1. The manufacturer lodges an application for assessment of his qualitysystem with a notified body.


— the name and address of the manufacturer,


— a written declaration specifying that no application has been lodgedwith any other notified body for the same products,


— an undertaking by the manufacturer to fulfil the obligations imposed bythe quality system approved,

— an undertaking by the manufacturer to keep the approved qualitysystem adequate and efficacious,

— where appropriate, the technical documentation on the types approvedand a copy of the EC type-examination certificates,


(i) any malfunction or deterioration in the characteristics and/orperformance of a device, as well as any inadequacy in thelabelling or the instructions for use which might lead to or mighthave led to the death of a patient or user or to a serious dete-rioration in his state of health;

(ii) any technical or medical reason connected with the characteristicsor the performance of a device for the reasons referred to in subpar-agraph (i) leading to a systematic recall of devices of the same typeby the manufacturer.

3.2. Under the quality system, each product or a representative sample of eachbatch is examined and the appropriate tests defined in the relevant standard

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▼B

(s) referred to in Article 5 or equivalent tests are carried out to ensure thatthe products conform to the type described in the EC type-examinationcertificate and fulfil the provisions of this Directive which apply to them.All the elements, requirements and provisionsadopted by the manufacturermust be documented in a systematic and orderly manner in the form ofwritten measures, procedures and instructions. This quality system docu-mentation must permit uniform interpretation of the quality programmes,quality plans, quality manuals and quality records.

It must include in particular an adequate description of:

— the quality objectives and the organizational structure, responsibilitiesand powers of the managerial staff with regard to product quality,

— the examinations and tests that will be carried out after manufacture; itmust be possible to trace back the calibration of the test equipmentadequately,

— the methods of monitoring the efficient operation of the quality system,

— the quality records, such as reports concerning inspections, tests, cali-bration and the qualifications of the staff concerned, etc.,

▼M5— where the final inspection and testing of the products, or elements

thereof, are carried out by a third party, the methods of monitoringthe efficient operation of the quality system and in particular the typeand extent of control applied to the third party.

▼BThe aforementioned checks do not apply to those aspects of the manufac-turing process designed to secure sterility.

3.3. The notified body audits the quality system to determine whether it meetsthe requirements referred to in section 3.2. It must presume that qualitysystems which implement the relevant harmonized standards conform tothese requirements.

The assessment team must include at least one member with pastexperience of assessments of the technology concerned. The assessmentprocedure must include an inspection on the manufacturer's premises and,in duly substantiated cases, on the premises of the manufacturer's suppliersto inspect the manufacturing processes.

The decision must be notified to the manufacturer. It must contain theconclusions of the inspection and a reasoned assessment.

3.4. The manufacturer must inform the notified body which approved thequality system of any plan for substantial changes to the quality system.

The notified body must assess the changes proposed and verify whetherafter these changes the quality system will still meet the requirementsreferred to in Section 3.2.

After receiving the abovementioned information it must notify the manu-facturer of its decision. This decision must contain the conclusions of theinspection and a reasoned assessment.

4. Surveillance


4.2. The manufacturer must allow the notified body access for inspectionpurposes to the inspection, testing and storage locations and supply itwith all relevant information, in particular:


— the technical documentation,

— the quality records, such as inspection reports, test data, calibrationdata, qualification reports of the staff concerned, etc.

4.3. The notified body must periodically carry out appropriate inspections andassessments to make sure that the manufacturer applies the quality systemand must supply the manufacturer with an assessment report.

4.4. In addition, the notified body may pay unannounced visits to the manu-facturer. At the time of such visits, the notified body may, where necessary,

1993L0042 — EN— 11.10.2007— 005.001— 46

▼B

carry out or ask for tests in order to check that the quality system isworking properly and that the production conforms to the requirementsof the Directive which apply to it. To this end, an adequate sample ofthe final products, taken on site by the notified body, must be examinedand the appropriate tests defined in the relevant standard(s) referred to inArticle 5 or equivalent tests must be carried out. Where one or more of thesamples fails to conform, the notified body must take the appropriatemeasures.

It must provide the manufacturer with an inspection report and, if a test hasbeen carried out, with a test report.


5.1. ►M5 The manufacturer or his authorised representative must, for a periodending at least five years, and in the case of implantable devices at least 15years, after the last product has been manufactured, make available to thenational authorities: ◄


— the documentation referred to in the seventh indent of Section 3.1,


— the decisions and reports from the notified body as referred to in thefinal indent of Section 3.4 and in Sections 4.3 and 4.4,

— where appropriate, the certificate of conformity referred to in Annex III.

▼M1__________

▼M56. Application to devices in Class IIa

In line with Article 11(2), this Annex may apply to products in Class IIa,subject to the following:

6.1. By way of derogation from Sections 2, 3.1 and 3.2, by virtue of thedeclaration of conformity the manufacturer ensures and declares that theproducts in Class IIa are manufactured in conformity with the technicaldocumentation referred to in Section 3 of Annex VII and meet therequirements of this Directive which apply to them.

6.2. For devices in Class IIa the notified body shall assess, as part of theassessment in Section 3.3, the technical documentation as described inSection 3 of Annex VII for at least one representative sample for eachdevice subcategory for compliance with the provisions of this Directive.


6.4. Further samples shall be assessed by the notified body as part of thesurveillance assessment referred to in Section 4.3.

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▼B

ANNEX VII


▼M51. The EC declaration of conformity is the procedure whereby the manu-

facturer or his authorised representative who fulfils the obligationsimposed by Section 2 and, in the case of products placed on the marketin a sterile condition and devices with a measuring function, the obligationsimposed by Section 5 ensures and declares that the products concernedmeet the provisions of this Directive which apply to them.

2. The manufacturer must prepare the technical documentation described inSection 3. The manufacturer or his authorised representative must make thisdocumentation, including the declaration of conformity, available to thenational authorities for inspection purposes for a period ending at leastfive years after the last product has been manufactured. In the case ofimplantable devices the period shall be at least 15 years after the lastproduct has been manufactured.

▼B3. The technical documentation must allow assessment of the conformity of

the product with the requirements of the Directive. It must include inparticular:

▼M5— a general description of the product, including any variants planned and

its intended use(s),

▼B— design drawings, methods of manufacture envisaged and diagrams of

components, sub-assemblies, circuits, etc.,

— the descriptions and explanations necessary to understand the above-mentioned drawings and diagrams and the operations of the product,

— the results of the risk analysis and a list of the standards referred to inArticle 5, applied in full or in part, and descriptions of the solutionsadopted to meet the essential requirements of the Directive if thestandards referred to in Article 5 have not been applied in full,

▼M5— in the case of products placed on the market in a sterile condition,

description of the methods used and the validation report,

▼B— the results of the design calculations and of the inspections carried out,

etc.; if the device is to be connected to other device(s) in order tooperate as intended, proof must be provided that it conforms to theessential requirements when connected to any such device(s) havingthe characteristics specified by the manufacturer,

▼M5— the solutions adopted as referred to in Annex I, Chapter I, Section 2,


— the clinical evaluation in accordance with Annex X,

▼B— the label and instructions for use.

▼M54. The manufacturer shall institute and keep up to date a systematic procedure

to review experience gained from devices in the post-production phase,including the provisions referred to in Annex X, and to implement appro-priate means to apply any necessary corrective actions, taking account ofthe nature and risks in relation to the product. He shall notify the competentauthorities of the following incidents immediately on learning of them:

▼B(i) any malfunction or deterioration in the characteristics and/or

performance of a device, as well as any inadequacy in the labellingor the instructions for use which might lead to or might have led to thedeath of a patient or user or to a serious deterioration in his state ofhealth;

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(ii) any technical or medical reason connected with the characteristics onthe performance of a device for the reasons referred to in subparagraph(i) leading to systematic recall of devices of the same type by themanufacturer.

5. With products placed on the market in sterile condition and Class I deviceswith a measuring function, the manufacturer must observe not only theprovisions laid down in this Annex but also one of the proceduresreferred to in ►M5 Annex II, IV, V or VI ◄. Application of the above-mentioned Annexes and the intervention by the notified body is limited to:

— in the case of products placed on the market in sterile condition, onlythe aspects of manufacture concerned with securing and maintainingsterile conditions,

— in the case of devices with a measuring function, only the aspects ofmanufacture concerned with the conformity of the products with themetrological requirements.

Section 6.1. of this Annex is applicable.

6. Application to devices in Class IIa

In line with Article 11 (2), this Annex may apply to products in Class IIa,subject to the following derogation:

6.1. where this Annex is applied in conjunction with the procedure referred toin Annex IV, V or VI, the declaration of conformity referred to in theabovementioned Annexes forms a single declaration. As regards thedeclaration based on this Annex, the manufacturer must ensure anddeclare that the product design meets the provisions of this Directivewhich apply to it.

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ANNEX VIII

STATEMENT CONCERNING DEVICES FOR SPECIAL PURPOSES

1. For custom-made devices or for devices intended for clinical investigations themanufacturer or his authorized representative►M5 __________ ◄ mustdraw up the statement containing the information stipulated in Section 2.

2. The statement must contain the following information:

2.1. for custom-made devices:

▼M5— the name and address of the manufacturer,

▼B— data allowing identification of the device in question,

— a statement that the device is intended for exclusive use by a particularpatient, together with the name of the patient,

— the name of the medical practitioner or other authorized person whomade out the prescription and, where applicable, the name of the clinicconcerned,

▼M5— the specific characteristics of the product as indicated by the

prescription,

▼B— a statement that the device in question conforms to the essential

requirements set out in Annex I and, where applicable, indicatingwhich essential requirements have not been fully met, together withthe grounds;

2.2. for devices intended for the clinical investigations covered by Annex X:

— data allowing identification of the device in question,

▼M5— the clinical investigation plan,

— the investigator's brochure,

— the confirmation of insurance of subjects,

— the documents used to obtain informed consent,

— a statement indicating whether or not the device incorporates, as anintegral part, a substance or human blood derivative referred to inSection 7.4 of Annex I,

— a statement indicating whether or not the device is manufacturedutilising tissues of animal origin as referred to in Directive 2003/32/EC,

▼B— the opinion of the ethics committee concerned and details of the aspects

covered by its opinion,

— the name of the medical practitioner or other authorized person and ofthe institution responsible for the investigations,

— the place, starting date and scheduled duration for the investigations,

— a statement that the device in question conforms to the essentialrequirements apart from the aspects covered by the investigations andthat, with regard to these aspects, every precaution has been taken toprotect the health and safety of the patient.

3. The manufacturer must also undertake to keep available for the competentnational authorities:

▼M53.1. For custom-made devices, documentation, indicating manufacturing site(s)

and allowing an understanding of the design, manufacture and perfor-mances of the product, including the expected performances, so as toallow assessment of conformity with the requirements of this Directive.

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The manufacturer must take all the measures necessary to ensure that themanufacturing process produces products which are manufactured inaccordance with the documentation mentioned in the first paragraph;

▼M53.2. For devices intended for clinical investigations, the documentation must

contain:

— a general description of the product and its intended use,

— design drawings, methods of manufacture envisaged, in particular asregards sterilisation, and diagrams of components, sub-assemblies,circuits, etc.,

— the descriptions and explanations necessary to understand the above-mentioned drawings and diagrams and the operation of the product,

— the results of the risk analysis and a list of the standards referred to inArticle 5, applied in full or in part, and descriptions of the solutionsadopted to meet the essential requirements of this Directive if thestandards referred to in Article 5 have not been applied,

— if the device incorporates, as an integral part, a substance or humanblood derivative referred to in Section 7.4 of Annex I, the data on thetests conducted in this connection which are required to assess thesafety, quality and usefulness of that substance or human blood deri-vative, taking account of the intended purpose of the device,

— if the device is manufactured utilising tissues of animal origin asreferred to in Directive 2003/32/EC, the risk management measures inthis connection which have been applied to reduce the risk of infection,

— the results of the design calculations, and of the inspections andtechnical tests carried out, etc.

The manufacturer must take all the measures necessary to ensure that themanufacturing process produces products which are manufactured inaccordance with the documentation referred to in the first paragraph ofthis Section.

The manufacturer must authorise the assessment, or audit where necessary,of the effectiveness of these measures.

4. The information contained in the declarations concerned by this Annexshall be kept for a period of time of at least five years. In the case ofimplantable devices the period shall be at least 15 years.

5. For custom-made devices, the manufacturer must undertake to review anddocument experience gained in the post-production phase, including theprovisions referred to in Annex X, and to implement appropriate meansto apply any necessary corrective action. This undertaking must include anobligation for the manufacturer to notify the competent authorities of thefollowing incidents immediately on learning of them and the relevantcorrective actions:

(i) any malfunction or deterioration in the characteristics and/orperformance of a device, as well as any inadequacy in the labellingor the instructions for use which might lead to or might have led to thedeath of a patient or user or to a serious deterioration in his state ofhealth;

(ii) any technical or medical reason connected with the characteristics orperformance of a device for the reasons referred to in subparagraph (i)leading to systematic recall of devices of the same type by the manu-facturer.

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ANNEX IX

CLASSIFICATION CRITERIA

I. DEFINITIONS

1. Definitions for the classification rules

1.1. Duration

Transient

Normally intended for continuous use for less than 60 minutes.

Shor t term

Normally intended for continuous use for not more than 30 days.

Long term

Normally intended for continuous use for more than 30 days.

1.2. Invasive devices

Invasive device

A device which, in whole or in part, penetrates inside the body, eitherthrough a body orifice or through the surface of the body.

Body ori f ice

Any natural opening in the body, as well as the external surface of theeyeball, or any permanent artificial opening, such as a stoma.

Surgical ly invasive device

An invasive device which penetrates inside the body through the surface ofthe body, with the aid or in the context of a surgical operation.

For the purposes of this Directive devices other than those referred to in theprevious subparagraph and which produce penetration other than throughan established body orifice, shall be treated as surgically invasive devices.

Implantable device

Any device which is intended:

— to be totally introduced into the human body or,

— to replace an epithelial surface or the surface of the eye,

by surgical intervention which is intended to remain in place after theprocedure.

Any device intended to be partially introduced into the human bodythrough surgical intervention and intended to remain in place after theprocedure for at least 30 days is also considered an implantable device.

1.3. Reusable surgical instrument

Instrument intended for surgical use by cutting, drilling, sawing, scratching,scraping, clamping, retracting, clipping or similar procedures, withoutconnection to any active medical device and which can be reused afterappropriate procedures have been carried out.

1.4. Active medical device

Any medical device operation of which depends on a source of electricalenergy or any source of power other than that directly generated by thehuman body or gravity and which acts by converting this energy. Medicaldevices intended to transmit energy, substances or other elements betweenan active medical device and the patient, without any significant change,are not considered to be active medical devices. ►M5 Stand alonesoftware is considered to be an active medical device. ◄

1.5. Active therapeutical device

Any active medical device, whether used alone or in combination withother medical devices, to support, modify, replace or restore biologicalfunctions or structures with a view to treatment or alleviation of anillness, injury or handicap.

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1.6. Active device for diagnosis

Any active medical device, whether used alone or in combination withother medical devices, to supply information for detecting, diagnosing,monitoring or treating physiological conditions, states of health, illnessesor congenital deformities.

▼M51.7. Central circulatory system

For the purposes of this Directive, ‘central circulatory system’ means thefollowing vessels:

arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to thebifurcatio aortae, arteriae coronariae, arteria carotis communis, arteriacarotis externa, arteria carotis interna, arteriae cerebrales, truncus brachio-cephalicus, venae cordis, venae pulmonales, vena cava superior, vena cavainferior.

▼B1.8. Central nervous system

For the purposes of this Directive, ‘central nervous system’ means brain,meninges and spinal cord.

II. IMPLEMENTING RULES

2. Implementing rules

2.1. Application of the classification rules shall be governed by the intendedpurpose of the devices.

2.2. If the device is intended to be used in combination with another device, theclassification rules shall apply separately to each of the devices. Acces-sories are classified in their own right separately from the device withwhich they are used.

2.3. Software, which drives a device or influences the use of a device, fallsautomatically in the same class.

2.4. If the device is not intended to be used solely or principally in a specificpart of the body, it must be considered and classified on the basis of themost critical specified use.

2.5. If several rules apply to the same device, based on the performancespecified for the device by the manufacturer, the strictest rules resultingin the higher classification shall apply.

▼M52.6. In calculating the duration referred to in Section 1.1 of Chapter I,

continuous use means ‘an uninterrupted actual use of the device for theintended purpose’. However where usage of a device is discontinued inorder for the device to be replaced immediately by the same or an identicaldevice this shall be considered an extension of the continuous use of thedevice.

▼BIII. CLASSIFICATION

1. Non-invasive devices

1.1. Rule 1

All non-invasive devices are in Class I, unless one of the rules set outhereinafter applies.

1.2. Rule 2

All non-invasive devices intended for channelling or storing blood, bodyliquids or tissues, liquids or gases for the purpose of eventual infusion,administration or introduction into the body are in Class IIa:

— if they may be connected to an active medical device in Class IIa or ahigher class,

— if they are intended for use for storing or channelling blood or otherbody liquids or for storing organs, parts of organs or body tissues,

in all other cases they are in Class I.

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1.3. Rule 3

All non-invasive devices intended for modifying the biological or chemicalcomposition of blood, other body liquids or other liquids intended forinfusion into the body are in Class IIb, unless the treatment consists offiltration, centrifugation or exchanges of gas, heat, in which case they are inClass IIa.

1.4. Rule 4

All non-invasive devices which come into contact with injured skin:

— are in Class I if they are intended to be used as a mechanical barrier, forcompression or for absorption of exudates,

— are in Class IIb if they are intended to be used principally with woundswhich have breached the dermis and can only heal by secondary intent,

— are in Class IIa in all other cases, including devices principally intendedto manage the micro-environment of a wound.

2. Invasive devices

2.1. Rule 5

►M5 All invasive devices with respect to body orifices, other thansurgically invasive devices and which are not intended for connection toan active medical device or which are intended for connection to an activemedical device in Class I: ◄

— are in Class I if they are intended for transient use,

— are in Class IIa if they are intended for short-term use, except if theyare used in the oral cavity as far as the pharynx, in an ear canal up tothe ear drum or in a nasal cavity, in which case they are in Class I,

— are in Class IIb if they are intended for long-term use, except if they areused in the oral cavity as far as the pharynx, in an ear canal up to theear drum or in a nasal cavity and are not liable to be absorbed by themucous membrane, in which case they are in Class IIa.

All invasive devices with respect to body orifices, other than surgicallyinvasive devices, intended for connection to an active medical device inClass IIa or a higher class, are in Class IIa.

▼M52.2. Rule 6

All surgically invasive devices intended for transient use are in Class IIaunless they are:

— intended specifically to control, diagnose, monitor or correct a defect ofthe heart or of the central circulatory system through direct contact withthese parts of the body, in which case they are in Class III,

— reusable surgical instruments, in which case they are in Class I,

— intended specifically for use in direct contact with the central nervoussystem, in which case they are in Class III,

— intended to supply energy in the form of ionising radiation in which casethey are in Class IIb,

— intended to have a biological effect or to be wholly or mainly absorbedin which case they are in Class IIb,

— intended to administer medicines by means of a delivery system, if thisis done in a manner that is potentially hazardous taking account of themode of application, in which case they are in Class IIb.

▼B2.3. Rule 7

All surgically invasive devices intended for short-term use are in Class IIaunless they are intended:

▼M5— either specifically to control, diagnose, monitor or correct a defect of the

heart or of the central circulatory system through direct contact withthese parts of the body, in which case they are in Class III,

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— or specifically for use in direct contact with the central nervous system,in which case they are in Class III,

— or to supply energy in the form of ionizing radiation in which case theyare in Class IIb,

— or to have a biological effect or to be wholly or mainly absorbed inwhich case they are in Class III,

— or to undergo chemical change in the body, except if the devices areplaced in the teeth, or to administer medicines, in which case they are inClass IIb.

2.4. Rule 8

All implantable devices and long-term surgically invasive devices are inClass IIb unless they are intended:

— to be placed in the teeth, in which case they are in Class IIa,

— to be used in direct contact with the heart, the central circulatory systemor the central nervous system, in which case they are in Class III,

— to have a biological effect or to be wholly or mainly absorbed, in whichcase they are in Class III,

— or to undergo chemical change in the body, except if the devices areplaced in the teeth, or to administer medicines, in which case they are inClass III.

3. Additional rules applicable to active devices

3.1. Rule 9

All active therapeutic devices intended to administer or exchange energy arein Class IIa unless their characteristics are such that they may administer orexchange energy to or from the human body in a potentially hazardous way,taking account of the nature, the density and site of application of theenergy, in which case they are in Class IIb.

All active devices intended to control or monitor the performance of activetherapeutic devices in Class IIb, or intended directly to influence theperformance of such devices are in Class IIb.

3.2. Rule 10

Active devices intended for diagnosis are in Class IIa:

— if they are intended to supply energy which will be absorbed by thehuman body, except for devices used to illuminate the patient's body, inthe visible spectrum,

— if they are intended to image in vivo distribution of radiopharmaceu-ticals,

— if they are intended to allow direct diagnosis or monitoring of vitalphysiological processes, unless they are specifically intended for moni-toring of vital physiological parameters, where the nature of variations issuch that it could result in immediate danger to the patient, for instancevariations in cardiac performance, respiration, activity of CNS in whichcase they are in Class IIb.

Active devices intended to emit ionizing radiation and intended for diag-nostic and therapeutic interventional radiology including devices whichcontrol or monitor such devices, or which directly influence theirperformance, are in Class IIb.

Rule 11

All active devices intended to administer and/or remove medicines, bodyliquids or other substances to or from the body are in Class IIa, unless thisis done in a manner:

— that is potentially hazardous, taking account of the nature of thesubstances involved, of the part of the body concerned and of themode of application in which case they are in Class IIb.

3.3. Rule 12

All other active devices are in Class I.

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4. Special Rules

4.1. Rule 13

All devices incorporating, as an integral part, a substance which, if usedseparately, can be considered to be a medicinal product, as defined inArticle 1 of Directive ►M5 2001/83/EC ◄, and which is liable to acton the human body with action ancillary to that of the devices, are inClass III.

▼M5All devices incorporating, as an integral part, a human blood derivative arein Class III.

▼B4.2. Rule 14

All devices used for contraception or the prevention of the transmission ofsexually transmitted diseases are in Class IIb, unless they are implantable orlong term invasive devices, in which case they are in Class III.

4.3. Rule 15

All devices intended specifically to be used for disinfecting, cleaning,rinsing or, when appropriate, hydrating contact lenses are in Class IIb.

All devices intended specifically to be used for disinfecting medical devicesare in Class IIa. ►M5 Unless they are specifically to be used for disin-fecting invasive devices in which case they are in Class IIb. ◄

This rule does not apply to products that are intended to clean medicaldevices other than contact lenses by means of physical action.

4.4. Rule 16

►M5 Devices ◄ specifically intended for recording of X-ray diagnosticimages are in Class IIa.

4.5. Rule 17

All devices manufactured utilizing animal tissues or derivatives renderednon-viable are Class III except where such devices are intended to comeinto contact with intact skin only.

5. Rule 18

By derogation from other rules, blood bags are in Class IIb.

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ANNEX X

CLINICAL EVALUATION

1. General provisions

▼M51.1. As a general rule, confirmation of conformity with the requirements

concerning the characteristics and performances referred to inSections 1 and 3 of Annex I, under the normal conditions of use ofthe device, and the evaluation of the side-effects and of the acceptabilityof the benefit/risk ratio referred to in Section 6 of Annex I, must bebased on clinical data. The evaluation of this data, hereinafter referred toas ‘clinical evaluation’, where appropriate taking account of any relevantharmonised standards, must follow a defined and methodologicallysound procedure based on:

1.1.1. Either a critical evaluation of the relevant scientific literature currentlyavailable relating to the safety, performance, design characteristics andintended purpose of the device, where:

— there is demonstration of equivalence of the device to the device towhich the data relates, and

— the data adequately demonstrate compliance with the relevantessential requirements.

1.1.2. Or a critical evaluation of the results of all clinical investigations made.

1.1.3. Or a critical evaluation of the combined clinical data provided in 1.1.1and 1.1.2.

1.1a In the case of implantable devices and devices in Class III clinicalinvestigations shall be performed unless it is duly justified to rely onexisting clinical data.

1.1b The clinical evaluation and its outcome shall be documented. This docu-mentation shall be included and/or fully referenced in the technicaldocumentation of the device.

1.1c The clinical evaluation and its documentation must be actively updatedwith data obtained from the post-market surveillance. Where post-marketclinical follow-up as part of the post-market surveillance plan for thedevice is not deemed necessary, this must be duly justified and docu-mented.

1.1d Where demonstration of conformity with essential requirements based onclinical data is not deemed appropriate, adequate justification for anysuch exclusion has to be given based on risk management output andunder consideration of the specifics of the device/body interaction, theclinical performances intended and the claims of the manufacturer.Adequacy of demonstration of conformity with the essential requirementsby performance evaluation, bench testing and pre-clinical evaluationalone has to be duly substantiated.

▼B1.2. All the data must remain confidential, in accordance with the provisions

of Article 20.

2. Clinical investigations

2.1. Objectives

The objectives of clinical investigation are:

— to verify that, under normal conditions of use, the performance of thedevices conform to those referred to in Section 3 of Annex I, and

— to determine any undesirable side-effects, under normal conditions ofuse, and assess whether they constitute risks when weighed againstthe intended performance of the device.

2.2. Ethical considerations

►M5 Clinical investigations must be carried out in accordance with theHelsinki Declaration adopted by the 18th World Medical Assembly inHelsinki, Finland, in 1964, as last amended by the World MedicalAssembly. ◄ It is mandatory that all measures relating to the protection

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of human subjects are carried out in the spirit of the HelsinkiDeclaration. This includes every step in the clinical investigation fromfirst consideration of the need and justification of the study to publicationof the results.

2.3. Methods

2.3.1. Clinical investigations must be performed on the basis of an appropriateplan of investigation reflecting the latest scientific and technicalknowledge and defined in such a way as to confirm or refute the manu-facturer's claims for the device; these investigations must include anadequate number of observations to guarantee the scientific validity ofthe conclusions.

2.3.2. The procedures used to perform the investigations must be appropriate tothe device under examination.

2.3.3. Clinical investigations must be performed in circumstances similar to thenormal conditions of use of the device.

2.3.4. All the appropriate features, including those involving the safety andperformances of the device, and its effect on patients must be examined.

▼M52.3.5. All serious adverse events must be fully recorded and immediately

notified to all competent authorities of the Member States in which theclinical investigation is being performed.

▼B2.3.6. The investigations must be performed under the responsibility of a

medical practitioner or another authorized qualified person in an appro-priate environment.

The medical practitioner or other authorized person must have access tothe technical and clinical data regarding the device.

2.3.7. The written report, signed by the medical practitioner or other authorizedperson responsible, must contain a critical evaluation of all the datacollected during the clinical investigation.

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ANNEX XI

CRITERIA TO BE MET FOR THE DESIGNATION OF NOTIFIEDBODIES

1. The notified body, its Director and the assessment and verification staff shallnot be the designer, manufacturer, supplier, installer or user of the deviceswhich they inspect, nor the authorized representative of any of these persons.They may not be directly involved in the design, construction, marketing ormaintenance of the devices, nor represent the parties engaged in theseactivities. This in no way precludes the possibility of exchanges oftechnical information between the manufacturer and the body.

2. The notified body and its staff must carry out the assessment and verificationoperations with the highest degree of professional integrity and the requisitecompetence in the field of medical devices and must be free from allpressures and inducements, particularly financial, which might influencetheir judgment or the results of the inspection, especially from persons orgroups of persons with an interest in the results of the verifications.

Should the notified body subcontract specific tasks connected with the estab-lishment and verification of the facts, it must first ensure that the subcon-tractor meets the provisions of the Directive and, in particular, of this Annex.The notified body shall keep at the disposal of the national authorities therelevant documents assessing the subcontractor's qualifications and the workcarried out by the subcontractor under this Directive.

3. The notified body must be able to carry out all the tasks assigned to suchbodies by one of Annexes II to VI and for which it has been notified, whetherthese tasks are carried out by the body itself or on its responsibility. Inparticular, it must have the necessary staff and possess the facilities neededto perform properly the technical and administrative tasks entailed inassessment and verification. ►M1 This presupposes the availability ofsufficient scientific staff within the organisation who possess experienceand knowledge sufficient to assess the medical functionality and performanceof devices for which it has been notified, having regard to the requirements ofthis Directive and, in particular, those set out in Annex I. ◄ It must alsohave access to the equipment necessary for the verifications required.

4. The notified body must have:

— sound vocational training covering all the assessment and verificationoperations for which the body has been designated,

— satisfactory knowledge of the rules on the inspections which they carryout and adequate experience of such inspections,

— the ability required to draw up the certificates, records and reports todemonstrate that the inspections have been carried out.

5. The impartiality of the notified body must be guaranteed. Their remunerationmust not depend on the number of inspections carried out, nor on the resultsof the inspections.

6. The body must take out civil liability insurance, unless liability is assumed bythe State under domestic legislation or the Member State itself carries out theinspections directly.

7. The staff of the notified body are bound to observe professional secrecy withregard to all information gained in the course of their duties (except vis-à-visthe competent administrative authorities of the State in which their activitiesare carried out) pursuant to this Directive or any provision of national lawputting it into effect.

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ANNEX XII

CE MARKING OF CONFORMITY

The CE conformity marking shall consist of the initials ‘CE’ taking the followingform:

— If the marking is reduced or enlarged the proportions given in the abovegraduated drawing must be respected.

— The various components of the CE marking must have substantially the samevertical dimension, which may not be less than 5 mm.

This minimum dimension may be waived for small-scale devices.

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DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 5 September 2007

amending Council Directive 90/385/EEC on the approximation of the laws of the Member Statesrelating to active implantable medical devices, Council Directive 93/42/EEC concerning medical

devices and Directive 98/8/EC concerning the placing of biocidal products on the market

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THEEUROPEAN UNION,

Having regard to the Treaty establishing the European Commu-nity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic andSocial Committee (1),

Acting in accordance with the procedure laid down in Article 251of the Treaty (2),

Whereas:

(1) Council Directive 93/42/EEC (3) requires the Commissionto submit a report to the Council, no later than five yearsfrom the date of implementation of that Directive,concerning: (i) information on incidents occurring follow-ing the placing of devices on the market, (ii) clinicalinvestigation carried out in accordance with the procedureset out in Annex VIII to Directive 93/42/EEC, and (iii)design examination and EC type examination of medicaldevices that incorporate, as an integral part, a substancewhich, if used separately, may be considered to be amedicinal product as defined in Directive 2001/83/EC ofthe European Parliament and of the Council of 6 November2001 on the Community code relating to medicinalproducts for human use (4) and which is liable to act uponthe body with action ancillary to that of the device.

(2) The Commission brought forward the conclusions of thatreport in its Communication to the Council and theEuropean Parliament on medical devices which, at therequest of the Member States, was expanded to cover allaspects of the Community regulatory framework formedical devices.

(3) This Communication was welcomed by the Council in itsConclusions on medical devices of 2 December 2003 (5). It

was also discussed by the European Parliament which on3 June 2003 adopted a resolution on the healthimplications of Directive 93/42/EEC (6).

(4) Following from the conclusions drawn in that Commu-nication it is necessary and appropriate to amend CouncilDirective 90/385/EEC (7), Directive 93/42/EEC and Direc-tive 98/8/EC of the European Parliament and of theCouncil (8).

(5) To ensure consistency of interpretation and implementationbetween Directives 93/42/EEC and 90/385/EEC the legalframework related to issues such as authorised representa-tive, the European databank, health protection measures,and the application of Directive 93/42/EEC as regardsmedical devices incorporating stable derivates of humanblood or human plasma, as introduced by Directive 2000/70/EC (9), should be extended to Directive 90/385/EEC. Theapplication of the provisions on medical devices incorpor-ating stable derivates of human blood or human plasmaincludes application of Directive 2002/98/EC of theEuropean Parliament and of the Council of 27 January2003 setting standards of quality and safety for thecollection, testing, processing, storage and distribution ofhuman blood and blood components and amendingDirective 2001/83/EC (10).

(6) It is necessary to clarify that software in its own right, whenspecifically intended by the manufacturer to be used for oneor more of the medical purposes set out in the definition ofa medical device, is a medical device. Software for generalpurposes when used in a healthcare setting is not a medicaldevice.

(7) Particular care should be taken to ensure that thereprocessing of medical devices does not endanger patients’safety or health. It is therefore necessary to provideclarification on the definition of the term ‘single use’, aswell as to make provision for uniform labelling and

21.9.2007 EN Official Journal of the European Union L 247/21

(1) OJ C 195, 18.8.2006, p. 14.(2) Opinion of the European Parliament of 29 March 2007 (not yet

published in the Official Journal) and Council Decision of 23 July2007.

(3) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation(EC) No 1882/2003 of the European Parliament and of the Council(OJ L 284, 31.10.2003, p. 1).

(4) OJ L 311, 28.11.2001, p. 67. Directive as last amended byRegulation (EC) No 1901/2006 of the European Parliament and ofthe Council (OJ L 378, 27.12.2006, p. 1).

(5) OJ C 20, 24.1.2004, p. 1.

(6) OJ C 68 E, 18.3.2004, p. 85.(7) OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation

(EC) No 1882/2003.(8) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission

Directive 2007/20/EC (OJ L 94, 4.4.2007, p. 23).(9) Directive 2000/70/EC of the European Parliament and of the

Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates ofhuman blood or human plasma (OJ L 313, 13.12.2000, p. 22).

(10) OJ L 33, 8.2.2003, p. 30.

instructions for use. Moreover, the Commission shouldengage in further analysis in order to see if additionalmeasures are appropriate to ensure a high level ofprotection for patients.

(8) In the light of technical innovation and the development ofinitiatives at the international level it is necessary toenhance the provisions on clinical evaluation, includingclarification that clinical data is generally required for alldevices regardless of classification and the possibility tocentralise data on clinical investigations in the Europeandatabank.

(9) In order to provide clearer evidence of the compliance ofcustom-made device manufacturers, an explicit requirementfor a post market production review system involvingincident reporting to authorities should be introduced, as isalready in place for other devices, and to enhance patientinformation, a requirement should be introduced that the‘Statement’ under Annex VIII to Directive 93/42/EECshould be available to the patient and that it shouldcontain the name of the manufacturer.

(10) In the light of technical progress in information technologyand medical devices, a process should be provided to allowinformation supplied by the manufacturer to be availableby other means.

(11) Manufacturers of Class I sterile and/or measuring medicaldevices should be given the option of using the full qualityassurance conformity assessment module in order toprovide them with more flexibility in the choice ofcompliance modules.

(12) In order to support market surveillance activities byMember States it is necessary and appropriate, in the caseof implantable devices, to increase the time period for theretention of documents for administrative purposes to atleast 15 years.

(13) For the appropriate and efficient functioning of Directive93/42/EEC as regards regulatory advice on classificationissues arising at national level, in particular on whether ornot a product falls under the definition of a medical device,it is in the interest of national market surveillance and thehealth and safety of humans to establish a procedure fordecisions on whether or not a product falls under themedical device definition.

(14) To ensure that, where a manufacturer does not have aregistered place of business in the Community, authoritieshave a single individual person authorised by themanufacturer whom they can address in matters relatingto the compliance of the devices with the Directives it isnecessary to introduce an obligation for such manufacturersto designate an authorised representative for a device. Thisdesignation should be effective at least for all devices of thesame model.

(15) To further ensure public health and safety it is necessary toprovide for a more consistent application of the provisionson health protection measures. Particular care should betaken to ensure that, when in use, the products do notendanger patients’ health or safety.

(16) In support of transparency in Community legislation,certain information related to medical devices and theirconformity with Directive 93/42/EEC, in particular infor-mation on registration, on vigilance reports and oncertificates, should be available to any interested partyand the general public.

(17) To better coordinate the application and efficiency ofnational resources when applied to issues related toDirective 93/42/EEC, the Member States should cooperatewith each other and at international level.

(18) As design for patient safety initiatives play an increasingrole in public health policy, it is necessary to expressly setout the need to consider ergonomic design in the essentialrequirements. In addition the level of training and knowl-edge of the user, such as in the case of a lay user, should befurther emphasised within the essential requirements. Themanufacturer should place particular emphasis on theconsequences of misuse of the product and its adverseeffects on the human body.

(19) In the light of experience gained regarding activities of boththe notified bodies and the authorities in the assessment ofdevices which require intervention of the appropriateauthorities for medicines and human blood derivativestheir duties and tasks should be clarified.

(20) Taking account of the growing importance of software inthe field of medical devices, be it as stand alone or assoftware incorporated in a device, validation of software inaccordance with the state of the art should be an essentialrequirement.

(21) In the light of the increased use of third Parties to carry outthe design and manufacture of devices on behalf of themanufacturer, it is important that the manufacturerdemonstrates that he applies adequate controls to the thirdparty to continue to ensure the efficient operating of thequality system.

(22) The classification rules are based on the vulnerability of thehuman body taking account of the potential risksassociated with the technical design and manufacture ofthe devices. Explicit prior authorisation with regard toconformity, including an assessment of the designdocumentation, is required for Class III devices to beplaced on the market. In performing its duties under thequality assurance and verification conformity assessmentmodules for all other classes of devices, it is essential andnecessary for a notified body, in order to be assured of the

L 247/22 EN Official Journal of the European Union 21.9.2007

compliance of the manufacturer with Directive 93/42/EEC,to review the design documentation for the medical device.The depth and extent of this review should be commensu-rate with the classification of the device, the novelty of theintended treatment, the degree of intervention, the noveltyof the technology or construction materials, and thecomplexity of the design and/or technology. This reviewcan be achieved by taking a representative example ofdesign documentation of one or more type(s) of devicesfrom those being manufactured. Further review(s), and inparticular the assessment of changes to the design thatcould affect conformity with the essential requirements,should be part of the surveillance activities of the notifiedbody.

(23) It is necessary to remove the incoherence in theclassification rules as a result of which invasive deviceswith respect to body orifices intended for connection to anactive Class I medical device were not classified.

(24) The measures necessary for the implementation ofDirective 90/385/EEC and Directive 93/42/EEC should beadopted in accordance with Council Decision 1999/468/ECof 28 June 1999 laying down the procedures for theexercise of implementing powers conferred on theCommission (1).

(25) In particular, power should be conferred on the Commis-sion to adapt classification rules for medical devices, toadapt the means by which the information needed to usemedical devices safely and properly may be set out, todetermine conditions for making certain informationpublicly available, to adapt the provisions on clinicalinvestigations set out in certain Annexes, to adoptparticular requirements for placing certain medical deviceson the market or putting them into service, and to takedecisions to withdraw such devices from the market forreasons of protection of health or safety. Since thosemeasures are of general scope and are designed to amend orsupplement Directive 90/385/EEC and Directive 93/42/EECby the modification or addition of non-essential elements,they must be adopted in accordance with the regulatoryprocedure with scrutiny provided for in Article 5a ofDecision 1999/468/EC.

(26) When, on imperative grounds of urgency, the normal timelimits for the regulatory procedure with scrutiny cannot becomplied with, the Commission should be able to use theurgency procedure provided for in Article 5a(6) of Decision1999/468/EC for taking decisions on withdrawal of certainmedical devices from the market and for the adoption ofparticular requirements for placing such devices on themarket or putting them into service for reasons ofprotection of health or safety.

(27) The Commission should give a mandate to CEN and/orCenelec to specify technical requirements and a suitablespecific label for phthalate-containing devices within 12months after entry into force of this Directive.

(28) Many Member States have established recommendationswith the aim of reducing or limiting the use of medicaldevices containing critical phthalates on children, pregnantand nursing women and other patients at risk. To enablemedical professionals to avoid such risks, devices whichpossibly release phthalates to the body of the patient shouldbe labelled accordingly.

(29) In accordance with the essential requirements on the designand manufacture of medical devices, manufacturers shouldavoid the use of substances that may possibly compromisethe health of patients, in particular of substances which arecarcinogenic, mutagenic or toxic to reproduction, andshould, as appropriate, strive to develop alternativesubstances or products with a lower risk potential.

(30) It should be clarified that alongside Directives 90/385/EECand 93/42/EEC, in vitro diagnostic medical devices, whichare the subject of Directive 98/79/EC of the EuropeanParliament and of the Council of 27 October 1998 on invitro diagnostic medical devices (2), should also be excludedfrom the scope of Directive 98/8/EC.

(31) In accordance with point 34 of the Interinstitutionalagreement on better law-making (3), Member States areencouraged to draw up, for themselves and in the interestsof the Community, their own tables illustrating, as far aspossible, the correlation between this Directive and thetransposition measures, and to make them public.

(32) Directives 90/385/EEC, 93/42/EEC and 98/8/EC shouldtherefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 90/385/EEC is hereby amended as follows:


(a) paragraph 2 shall be amended as follows:

(i) point (a) shall be replaced by the following:

‘(a) “medical device” means any instrument,apparatus, appliance, software, material orother article, whether used alone or incombination, together with any accessories,including the software intended by its


(1) OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

(2) OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation(EC) No 1882/2003.

(3) OJ C 321, 31.12.2003, p. 1.

manufacturer to be used specifically fordiagnostic and/or therapeutic purposes andnecessary for its proper application,intended by the manufacturer to be usedfor human beings for the purpose of:

— diagnosis, prevention, monitoring,treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alle-viation of or compensation for aninjury or handicap,

— investigation, replacement or modifi-cation of the anatomy or of aphysiological process,

— control of conception,

and which does not achieve its principalintended action in or on the human bodyby pharmacological, immunological ormetabolic means, but which may beassisted in its function by such means;’

(ii) points (d), (e) and (f) shall be replaced by thefollowing:

‘(d) “custom-made device” means any devicespecifically made in accordance with a dulyqualified medical practitioner's written pre-scription which gives, under his responsi-bility, specific design characteristics and isintended for the sole use of a particularpatient. Mass-produced devices which needto be adapted to meet the specific require-ments of the medical practitioner or anyother professional user shall not be con-sidered to be custom-made devices;

(e) “device intended for clinical investigation”means any device intended for use by aduly qualified medical practitioner whenconducting clinical investigations asreferred to in Section 2.1 of Annex 7 inan adequate human clinical environment.

For the purpose of conducting clinicalinvestigation, any other person who, byvirtue of his professional qualifications, isauthorised to carry out such investigationshall be accepted as equivalent to a dulyqualified medical practitioner;

(f) “intended purpose” means the use forwhich the device is intended according tothe data supplied by the manufacturer on

the labelling, in the instructions and/or inpromotional material;’

(iii) the following points shall be added:

‘(j) “authorised representative” means any nat-ural or legal person established in theCommunity who, explicitly designated bythe manufacturer, acts and may beaddressed by authorities and bodies in theCommunity instead of the manufacturerwith regard to the latter's obligations underthis Directive;

(k) “clinical data” means the safety and/orperformance information that is generatedfrom the use of a device. Clinical data aresourced from:

— clinical investigation(s) of the deviceconcerned, or

— clinical investigation(s) or other stu-dies reported in the scientific litera-ture, of a similar device for whichequivalence to the device in questioncan be demonstrated, or

— published and/or unpublished reportson other clinical experience of eitherthe device in question or a similardevice for which equivalence to thedevice in question can be demon-strated.’;

(b) paragraph 3 shall be replaced by the following:

‘3. Where an active implantable medical device isintended to administer a substance defined as amedicinal product within the meaning of Article 1 ofDirective 2001/83/EC (*), that device shall be gov-erned by this Directive, without prejudice to theprovisions of Directive 2001/83/EC with regard to themedicinal product.

(*) OJ L 311, 28.11.2001, p. 67. Directive as lastamended by Regulation (EC) No 1901/2006 (OJL 378, 27.12.2006, p. 1)’

(c) paragraph 4 shall be replaced by the following:

‘4. Where an active implantable medical deviceincorporates, as an integral part, a substance which,if used separately, may be considered to be a medicinalproduct within the meaning of Article 1 of Directive2001/83/EC and which is liable to act upon the


human body with action that is ancillary to that of thedevice, that device shall be evaluated and authorised inaccordance with this Directive.’;

(d) the following paragraph shall be inserted:

‘4a. Where a device incorporates, as an integral part,a substance which, if used separately, may beconsidered to be a medicinal product constituent ora medicinal product derived from human blood orhuman plasma within the meaning of Article 1 ofDirective 2001/83/EC and which is liable to act uponthe human body with action that is ancillary to that ofthe device, hereinafter referred to as a “human bloodderivative”, that device shall be assessed andauthorised in accordance with this Directive.’;

(e) paragraph 5 shall be replaced by the following:

‘5. This Directive constitutes a specific Directivewithin the meaning of Article 1(4) of Directive 2004/108/EC (*).

(*) Directive 2004/108/EC of the European Parlia-ment and of the Council of 15 December 2004on the approximation of the laws of the MemberStates relating to electromagnetic compatibility(OJ L 390, 31.12.2004, p. 24).’;

(f) the following paragraph shall be added:

‘6. This Directive shall not apply to:

(a) medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls underthat Directive or this Directive, particularaccount shall be taken of the principal modeof action of the product;

(b) human blood, blood products, plasma or bloodcells of human origin or to devices whichincorporate at the time of placing on the marketsuch blood products, plasma or cells with theexception of devices referred to in paragraph 4a;

(c) transplants or tissues or cells of human origin orto products incorporating or derived fromtissues or cells of human origin, with theexception of devices referred to in paragraph 4a;

(d) transplants or tissues or cells of animal origin,unless a device is manufactured utilising animaltissue which is rendered non-viable or non-viable products derived from animal tissue.’;

2. Article 2 shall be replaced by the following:

‘Article 2

Member States shall take all necessary steps to ensure thatthe devices may be placed on the market and/or put intoservice only if they comply with the requirements laiddown in this Directive when duly supplied, properlyimplanted and/or properly installed, maintained and usedin accordance with their intended purposes.’;


‘Article 3

The active implantable medical devices referred to inArticle 1(2)(c), (d) and (e), hereinafter referred to as“devices”, shall satisfy the essential requirements set out inAnnex 1 which apply to them, account being taken of theintended purpose of the devices concerned.

Where a relevant hazard exists, devices which are alsomachinery within the meaning of Article 2(a) of Directive2006/42/EC of the European Parliament and of the Councilof 17 May 2006 on machinery (*) shall also meet theessential health and safety requirements set out in Annex Ito that Directive to the extent to which those essentialhealth and safety requirements are more specific than theessential requirements set out in Annex 1 to this Directive.

(*) OJ L 157, 9.6.2006, p. 24.’;

4. in Article 4, paragraphs 1, 2 and 3 shall be replaced by thefollowing:

‘1. Member States shall not create any obstacle to theplacing on the market or the putting into service withintheir territory of devices complying with the provisions ofthis Directive and bearing the CE marking provided for inArticle 12, which indicates that they have been the subjectof an assessment of their conformity in accordance withArticle 9.

2. Member States shall not create any obstacles to:

— devices intended for clinical investigations being madeavailable to duly qualified medical practitioners orauthorised persons for that purpose if they satisfy theconditions laid down in Article 10 and in Annex 6,

— custom-made devices being placed on the market andput into service if they satisfy the conditions laiddown in Annex 6 and are accompanied by thestatement, which shall be available to the particularidentified patient, referred to in that Annex.

These devices shall not bear the CE marking.


3. At trade fairs, exhibitions, demonstrations, etc.,Member States shall not create any obstacle to the showingof devices which do not conform to this Directive, providedthat a visible sign clearly indicates that such devices do notconform and cannot be marketed or put into service untilthey have been made to comply by the manufacturer or hisauthorised representative.’;


‘Article 5

1. Member States shall presume compliance with theessential requirements referred to in Article 3 in respect ofdevices which are in conformity with the relevant nationalstandards adopted pursuant to the harmonised standardsthe references of which have been published in the OfficialJournal of the European Union; Member States shall publishthe references of such national standards.

2. For the purposes of this Directive, reference toharmonised standards also includes the monographs ofthe European Pharmacopoeia notably on interactionbetween medicinal products and materials used in devicescontaining such medicinal products, the references ofwhich have been published in the Official Journal of theEuropean Union.’;


(a) in paragraph 1 the reference ‘83/189/EEC’ shall bereplaced by the reference

‘98/34/EC (*)

(*) Directive 98/34/EC of the European Parliamentand of the Council of 22 June 1998 laying downa procedure for the provision of information inthe field of technical standards and regulationsand of rules on Information Society services (OJL 204, 21.7.1998, p. 37). Directive as lastamended by the 2003 Act of Accession.’;


‘2. The Commission shall be assisted by a standingcommittee (hereinafter referred to as the Committee).

3. Where reference is made to this paragraph,Articles 5 and 7 of Decision 1999/468/EC shallapply, having regard to the provisions of Article 8thereof.

The period laid down in Article 5(6) of Decision1999/468/EC shall be set at three months.

4. Where reference is made to this paragraph,Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions ofArticle 8 thereof.

5. Where reference is made to this paragraph,Article 5a(1), (2), (4) and (6), and Article 7 of

Decision 1999/468/EC shall apply, having regard tothe provisions of Article 8 thereof.’;


‘Article 8

1. Member States shall take the necessary steps to ensurethat information brought to their knowledge regarding theincidents mentioned below involving a device is recordedand evaluated in a centralised manner:

(a) any malfunction of or deterioration in the character-istics and performances of a device, as well as anyinadequacy in the labelling or in the instructions foruse which might lead to or might have led to the deathof a patient or user or to a serious deterioration in hisstate of health;

(b) any technical or medical reason in relation to thecharacteristics or performances of a device for thereasons referred to in point (a), leading to systematicrecall of devices of the same type by the manufacturer.

2. Where a Member State requires medical practitionersor the medical institutions to inform the competentauthorities of any incidents referred to in paragraph 1, itshall take the necessary steps to ensure that themanufacturer of the device concerned, or his authorisedrepresentative, is also informed of the incident.

3. After carrying out an assessment, if possible togetherwith the manufacturer or his authorised representative,Member States shall, without prejudice to Article 7,immediately inform the Commission and the otherMember States of measures that have been taken or arecontemplated to minimise the recurrence of the incidentsreferred to in paragraph 1, including information on theunderlying incidents.

4. The measures necessary for the implementation of thisArticle shall be adopted in accordance with the regulatoryprocedure referred to in Article 6(3).’;


(a) paragraph 8 shall be replaced by the following:

‘8. Decisions taken by the notified bodies inaccordance with Annexes 2, 3 and 5 shall be validfor a maximum of five years and may be extended onapplication, made at a time agreed in the contractsigned by both Parties, for further periods of amaximum length of five years.’;

(b) the following paragraph shall be added:

‘10. The measures designed to amend non-essentialelements of this Directive, inter alia by supplementingit, relating to the means by which, in the light of


technical progress and considering the intended usersof the devices concerned, the information laid downin Annex 1 Section 15 may be set out shall be adoptedin accordance with the regulatory procedure withscrutiny referred to in Article 6(4).’;

9. Article 9a shall be replaced by the following:

‘Article 9a

1. A Member State shall submit a duly substantiatedrequest to the Commission and ask it to take the necessarymeasures in the following situations:

— that Member State considers that the conformity of adevice or family of devices should be established, byway of derogation from the provisions of Article 9, byapplying solely one of the given procedures chosenfrom among those referred to in Article 9,

— that Member State considers that a decision is requiredas to whether a particular product or product groupfalls within the definition of Article 1(2)(a), (c), (d) or(e).

Where measures are deemed necessary pursuant to the firstsubparagraph of this paragraph they shall be adopted inaccordance with the regulatory procedure referred to inArticle 6(3).

2. The Commission shall inform the Member States of themeasures taken.’;


(a) in paragraph 1, the word ‘his’ shall be replaced by theword ‘the’.

(b) the second subparagraph of paragraph 2 shall bereplaced by the following:

‘Member States may, however, authorise manufac-turers to start the clinical investigations in questionbefore the expiry of the 60-day period, provided thatthe ethics committee concerned has issued a favour-able opinion with respect to the investigationprogramme in question including its review of theclinical investigation plan.’;


‘3. The Member States shall, if necessary, take theappropriate steps to ensure public health and publicpolicy. Where a clinical investigation is refused orhalted by a Member State, that Member State shallcommunicate its decision and the grounds therefor toall Member States and the Commission. Where aMember State has called for a significant modificationor temporary interruption of a clinical investigation,that Member State shall inform the Member Statesconcerned about its actions and the grounds for theactions taken.’;

(d) the following paragraphs shall be added:

‘4. The manufacturer or his authorised representa-tive shall notify the competent authorities of theMember States concerned of the end of the clinicalinvestigation, with a justification in case of earlytermination. In the case of early termination of theclinical investigation on safety grounds this notifica-tion shall be communicated to all Member States andthe Commission. The manufacturer or his authorisedrepresentative shall keep the report referred to inpoint 2.3.7 of Annex 7 at the disposal of thecompetent authorities.

5. Clinical investigations shall be conducted inaccordance with the provisions of Annex 7. Themeasures designed to amend non-essential elementsof this Directive relating to the provisions on clinicalinvestigation in Annex 7 shall be adopted inaccordance with the regulatory procedure withscrutiny referred to in Article 6(4).’;

11. the following Articles shall be inserted:

‘Article 10a

1. Any manufacturer who, under his own name, placesdevices on the market in accordance with the procedurereferred to in Article 9(2) shall inform the competentauthorities of the Member State in which he has hisregistered place of business of the address of the registeredplace of business and the description of the devicesconcerned.

Member States may request to be informed of all dataallowing for the devices to be identified together with thelabel and the instructions for use when the devices are putinto service within their territory.

2. Where a manufacturer who places a device on themarket under his own name does not have a registeredplace of business in a Member State, he shall designate asingle authorised representative in the European Union.

For devices referred to in the first subparagraph ofparagraph 1 the authorised representative shall informthe competent authority of the Member State in which hehas his registered place of business of all details as referredto in paragraph 1.

3. The Member States shall on request inform the otherMember States and the Commission of the details referredto in the first subparagraph of paragraph 1 given by themanufacturer or authorised representative.

Article 10b

1. Regulatory data in accordance with this Directive shallbe stored in a European databank accessible to thecompetent authorities to enable them to carry out theirtasks relating to this Directive on a well-informed basis.


The databank shall contain the following:

(a) data relating to certificates issued, modified, supple-mented, suspended, withdrawn or refused accordingto the procedures as laid down in Annexes 2 to 5;

(b) data obtained in accordance with the vigilanceprocedure as defined in Article 8;

(c) data relating to clinical investigations referred to inArticle 10.

2. Data shall be forwarded in a standardised format.

3. The measures necessary for the implementation ofparagraphs 1 and 2 of this Article, in particular paragraph 1(c), shall be adopted in accordance with the regulatoryprocedure referred to in Article 6(3).

Article 10c

Where a Member State considers in relation to a givenproduct or group of products that, in order to ensureprotection of health and safety and/or to ensure that publichealth requirements are observed, such products should bewithdrawn from the market, or their placing on the marketand putting into service should be prohibited, restricted orsubjected to particular requirements, it may take anynecessary and justified transitional measures.

The Member State shall then inform the Commission andall the other Member States of the transitional measures,giving the reasons for its decision.

The Commission shall, whenever possible, consult theinterested Parties and the Member States. The Commissionshall adopt its opinion, indicating whether the nationalmeasures are justified or not. The Commission shall informall the Member States and the consulted interested Parties.

When appropriate, the necessary measures designed toamend non-essential elements of this Directive, bysupplementing it, relating to withdrawal from the market,prohibition of placing on the market and putting intoservice of a certain product or group of products or torestrictions or introduction of particular requirementstherefor, shall be adopted in accordance with the regulatoryprocedure with scrutiny referred to in Article 6(4). Onimperative grounds of urgency, the Commission may usethe urgency procedure referred to in Article 6(5).’;


(a) in paragraph 2, the following subparagraph shall beadded: ‘When appropriate in the light of technicalprogress, the detailed measures necessary to ensure aconsistent application of the criteria set out inAnnex 8 to this Directive for the designation ofbodies by the Member States shall be adopted inaccordance with the regulatory procedure referred toin Article 6(3).’;

(b) in paragraph 4, the words ‘agent established in theCommunity’ shall be replaced by the words‘authorised representative’;

(c) the following paragraphs shall be added:

‘5. The notified body shall inform its competentauthority about all certificates issued, modified,supplemented, suspended, withdrawn or refused andthe other notified bodies within the scope of thisDirective about certificates suspended, withdrawn orrefused and, on request, about certificates issued. Thenotified body shall also make available, on request, alladditional relevant information.

6. Where a notified body finds that pertinentrequirements of this Directive have not been met orare no longer met by the manufacturer or that acertificate should not have been issued, it shall, takingaccount of the principle of proportionality, suspendor withdraw the certificate issued or place anyrestrictions on it unless compliance with suchrequirements is ensured by the implementation ofappropriate corrective measures by the manufacturer.

In the case of suspension or withdrawal of thecertificate or of any restriction placed on it or in caseswhere an intervention of the competent authoritymay become necessary, the notified body shall informits competent authority thereof.

The Member State shall inform the other MemberStates and the Commission.

7. The notified body shall, on request, supply allrelevant information and documents, including bud-getary documents, required to enable the MemberState to verify compliance with the criteria laid downin Annex 8.’;


‘Article 13

Without prejudice to Article 7

(a) where a Member State establishes that the CE markinghas been affixed unduly or is missing in violation ofthis Directive, the manufacturer or his authorisedrepresentative established within the Community shallbe obliged to end the infringement under conditionsimposed by the Member State;

(b) where non-compliance continues, the Member Statemust take all appropriate measures to restrict orprohibit the placing on the market of the device inquestion or to ensure that it is withdrawn from themarket in accordance with the procedures laid downin Article 7.


Those provisions shall also apply where the CE marking hasbeen affixed in accordance with the procedures in thisDirective, but inappropriately, on products that are notcovered by this Directive.’;


(a) the first paragraph shall be replaced by the following:

‘Any decision taken pursuant to this Directive

(a) to refuse or restrict the placing on the market orthe putting into service of a device or thecarrying out of clinical investigations;

or

(b) to withdraw devices from the market

shall state the exact grounds on which it is based. Sucha decision shall be notified without delay to the partyconcerned, who shall at the same time be informed ofthe remedies available to him under the laws in forcein the Member State in question and of the time limitsto which such remedies are subject.’;

(b) in the second paragraph the words ‘established in theCommunity’ shall be deleted;


‘Article 15

1. Without prejudice to the existing national provisionsand practices on medical confidentiality, Member Statesshall ensure that all the Parties involved in the applicationof this Directive are bound to observe confidentiality withregard to all information obtained in carrying out theirtasks.

This does not affect the obligations of Member States andnotified bodies with regard to mutual information and thedissemination of warnings, nor the obligations of thepersons concerned to provide information under criminallaw.

2. The following information shall not be treated asconfidential:

(a) information on the registration of persons responsiblefor placing devices on the market in accordance withArticle 10a;

(b) information to users sent out by the manufacturer,authorised representative or distributor in relation to ameasure in accordance with Article 8;

(c) information contained in certificates issued, modified,supplemented, suspended or withdrawn.

3. The measures designed to amend non-essentialelements of this Directive, inter alia by supplementing it,relating to the determination of the conditions under whichinformation other than that referred to in paragraph 2, andin particular concerning any obligation for manufacturersto prepare and make available a summary of theinformation and data related to the device, may be madepublicly available shall be adopted in accordance with theregulatory procedure with scrutiny referred to in Article 6(4).’;

16. the following Article shall be inserted:

‘Article 15a

Member States shall take appropriate measures to ensurethat the competent authorities of the Member Statescooperate with each other and with the Commission andtransmit to each other the information necessary to enablethis Directive to be applied uniformly.

The Commission shall provide for the organisation of anexchange of experience between the competent authoritiesresponsible for market surveillance in order to coordinatethe uniform application of this Directive.

Without prejudice to the provisions of this Directive,cooperation may be part of initiatives developed at aninternational level.’;

17. Annexes 1 to 7 shall be amended in accordance withAnnex I to this Directive.

Article 2

Directive 93/42/EEC is hereby amended as follows:


(a) paragraph 2 shall be amended as follows:

(i) in point (a) the introductory phrase shall bereplaced by the following:

‘“medical device” means any instrument, appar-atus, appliance, software, material or otherarticle, whether used alone or in combination,including the software intended by its manufac-turer to be used specifically for diagnostic and/ortherapeutic purposes and necessary for itsproper application, intended by the manufac-turer to be used for human beings for thepurpose of:’;

(ii) in the third paragraph of point (d) the words ‘arenot’ shall be replaced by the words ‘shall not be’;


(iii) the following points shall be added:

‘(k) “clinical data” means the safety and/orperformance information that is generatedfrom the use of a device. Clinical data aresourced from:

— clinical investigation(s) of the deviceconcerned; or

— clinical investigation(s) or other stu-dies reported in the scientific litera-ture, of a similar device for whichequivalence to the device in questioncan be demonstrated; or

— published and/or unpublished reportson other clinical experience of eitherthe device in question or a similardevice for which equivalence to thedevice in question can be demon-strated;

(l) “device subcategory” means a set of deviceshaving common areas of intended use orcommon technology;

(m) “generic device group” means a set ofdevices having the same or similar intendeduses or commonality of technology allow-ing them to be classified in a genericmanner not reflecting specific characteris-tics;

(n) “single use device” means a device intendedto be used once only for a single patient.’;


‘3. Where a device is intended to administer amedicinal product within the meaning of Article 1 ofDirective 2001/83/EC (*), that device shall be gov-erned by this Directive, without prejudice to theprovisions of Directive 2001/83/EC with regard to themedicinal product.

If, however, such a device is placed on the market insuch a way that the device and the medicinal productform a single integral product which is intendedexclusively for use in the given combination andwhich is not reusable, that single product shall begoverned by Directive 2001/83/EC. The relevantessential requirements of Annex I to this Directive

shall apply as far as safety and performance-relateddevice features are concerned.

(*) Directive 2001/83/EC of the European Parlia-ment and of the Council of 6 November 2001on the Community code relating to medicinalproducts for human use (OJ L 311, 28.11.2001,p. 67). Directive as last amended by Regulation(EC) No 1901/2006 (OJ L 378, 27.12.2006,p. 1).’;

(c) in paragraph 4:

(i) the reference ‘65/65/EEC’ shall be replaced by thereference ‘2001/83/EC’;

(ii) the words ‘that device must’ shall be replaced bythe words ‘that device shall’;

(d) in paragraph 4a:

(i) the reference ‘89/381/EEC’ shall be replaced bythe reference ‘2001/83/EC’;

(ii) the words ‘that device must’ shall be replaced bythe words ‘that device shall’;

(e) paragraph 5 shall be amended as follows:

(i) The introductory phrase shall be replaced by thefollowing:

‘This Directive shall not apply to:’;

(ii) point (c) shall be replaced by the following:

‘(c) medicinal products covered by Directive2001/83/EC. In deciding whether a productfalls under that Directive or this Directive,particular account shall be taken of theprincipal mode of action of the product;’;

(iii) point (f) shall be replaced by the following:

‘(f) transplants or tissues or cells of humanorigin nor to products incorporating orderived from tissues or cells of humanorigin, with the exception of devicesreferred to in paragraph 4a.’;

(f) paragraph 6 shall be replaced by the following:

‘6. Where a device is intended by the manufacturerto be used in accordance with both the provisions onpersonal protective equipment in Council Directive


89/686/EEC (*) and this Directive, the relevant basichealth and safety requirements of Directive 89/686/EEC shall also be fulfilled.

(*) Council Directive 89/686/EEC of 21 December1989 on the approximation of the laws of theMember States relating to personal protectiveequipment (OJ L 399, 30.12.1989, p. 18).Directive as last amended by Regulation (EC)No 1882/2003 of the European Parliament andof the Council (OJ L 284, 31.10.2003, p. 1).’

(g) paragraphs 7 and 8 shall be replaced by the following:

‘7. This Directive is a specific Directive within themeaning of Article 1(4) of Directive 2004/108/EC ofthe European Parliament and of the Council (*).

8. This Directive shall not affect the application ofCouncil Directive 96/29/Euratom of 13 May 1996laying down basic safety standards for the protectionof the health of workers and the general public againstthe dangers arising from ionising radiation (**), nor ofCouncil Directive 97/43/Euratom of 30 June 1997 onhealth protection of individuals against the dangers ofionising radiation in relation to medical expo-sure (***).

(*) Directive 2004/108/EC of the European Parlia-ment and of the Council of 15 December 2004on the approximation of the laws of the MemberStates relating to electromagnetic compatibility(OJ L 390, 31.12.2004, p. 24).

(**) OJ L 159, 29.6.1996, p. 1.(***) OJ L 180, 9.7.1997, p. 22.’

2. in Article 3 the following paragraph shall be added:

‘Where a relevant hazard exists, devices which are alsomachinery within the meaning of Article 2(a) of Directive2006/42/EC of the European Parliament and of the Councilof 17 May 2006 on machinery (*) shall also meet theessential health and safety requirements set out in Annex Ito that Directive to the extent to which those essentialhealth and safety requirements are more specific than theessential requirements set out in Annex I to this Directive.

(*) OJ L 157, 9.6.2006, p. 24.’

3. the second indent of Article 4(2) shall be replaced by thefollowing:

‘— custom-made devices being placed on the market andput into service if they meet the conditions laid downin Article 11 in combination with Annex VIII; ClassIIa, IIb and III devices shall be accompanied by thestatement referred to in Annex VIII, which shall beavailable to the particular patient identified by name,an acronym or a numerical code.’;

4. in Article 6(1) the reference ‘83/189/EEC’ shall be replacedby the reference ‘98/34/EC (*)

(*) Directive 98/34/EC of the European Parliament and ofthe Council of 22 June 1998 laying down a procedurefor the provision of information in the field oftechnical standards and regulations and of rules onInformation Society services (OJ L 204, 21.7.1998,p. 37). Directive as last amended by the 2003 Act ofAccession.’


‘Article 7

1. The Commission shall be assisted by the Committee setup by Article 6(2) of Directive 90/385/EEC, hereinafterreferred to as “the Committee”.

2. Where reference is made to this paragraph, Articles 5and 7 of Decision 1999/468/EC shall apply, having regardto the provisions of Article 8 thereof.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shallapply, having regard to the provisions of Article 8 thereof.

4. Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/ECshall apply, having regard to the provisions of Article 8thereof.’;

6. In Article 8 paragraph 2 shall be replaced by the following:

‘2. The Commission shall enter into consultation with theParties concerned as soon as possible. Where, after suchconsultation, the Commission finds that:

(a) the measures are justified:

(i) it shall immediately so inform the Member Statewhich took the measures and the other MemberStates. Where the decision referred to inparagraph 1 is attributed to shortcomings inthe standards, the Commission shall, afterconsulting the Parties concerned, bring thematter before the Committee referred to inArticle 6(1) within two months if the MemberState which has taken the decision intends tomaintain it and shall initiate the advisoryprocedure referred to in Article 6(2);

(ii) when necessary in the interests of public health,appropriate measures designed to amend non-essential elements of this Directive relating towithdrawal from the market of devices referredto in paragraph 1 or to prohibition or restrictionof their placement on the market or being putinto service or to introduction of particularrequirements in order for such products to beput on the market, shall be adopted in


accordance with the regulatory procedure withscrutiny referred to in Article 7(3). On impera-tive grounds of urgency, the Commission mayuse the urgency procedure referred to in Article 7(4);

(b) the measures are unjustified, it shall immediately soinform the Member State which took the measuresand the manufacturer or his authorised representa-tive.’;

7. In Article 9 paragraph 3 shall be replaced by the following:

‘3. Where a Member State considers that the classificationrules set out in Annex IX require adaptation in the light oftechnical progress and any information which becomesavailable under the information system provided for inArticle 10, it may submit a duly substantiated request to theCommission and ask it to take the necessary measures foradaptation of classification rules. The measures designed toamend non-essential elements of this Directive relating toadaptation of classification rules shall be adopted inaccordance with the regulatory procedure with scrutinyreferred to in Article 7(3).’;


(a) in paragraph 2, the words ‘established in theCommunity’ shall be deleted;


‘3. After carrying out an assessment, if possibletogether with the manufacturer or his authorisedrepresentative, Member States shall, without prejudiceto Article 8, immediately inform the Commission andthe other Member States of measures that have beentaken or are contemplated to minimise the recurrenceof the incidents referred to in paragraph 1, includinginformation on the underlying incidents.’;

(c) the following paragraph shall be added:

‘4. Any appropriate measures to adopt proceduresto implement this Article shall be adopted inaccordance with the regulatory procedure referred toin Article 7(2).’;


(a) in paragraphs 8 and 9 the words ‘established in theCommunity’ shall be deleted;

(b) in paragraph 11, the words ‘Annexes II and III’ shall bereplaced by the words ‘Annexes II, III, V and VI’ andthe words ‘for further periods of five years’ shall bereplaced by the words ‘for further periods of amaximum length of five years’;


‘14. The measures designed to amend non-essentialelements of this Directive, by supplementing it,relating to the means by which, in the light oftechnical progress and considering the intended usersof the devices concerned, the information laid downin Annex I Section 13.1 may be set out, shall beadopted in accordance with the regulatory procedurewith scrutiny referred to in Article 7(3).’;


(a) the title shall be replaced by ‘Particular procedure forsystems and procedure packs and procedure forsterilisation’;


‘3. Any natural or legal person who sterilises, for thepurpose of placing on the market, systems orprocedure packs referred to in paragraph 2 or otherCE-marked medical devices designed by their manu-facturers to be sterilised before use, shall, at his choice,follow one of the procedures referred to in Annex II orV. The application of the abovementioned Annexesand the intervention of the notified body are limitedto the aspects of the procedure relating to theobtaining of sterility until the sterile package isopened or damaged. The person shall draw up adeclaration stating that sterilisation has been carriedout in accordance with the manufacturer's instruc-tions.’;

(c) in paragraph 4, the third sentence shall be replaced bythe following:

‘The declarations referred to in paragraphs 2 and 3shall be kept at the disposal of the competentauthorities for a period of five years.’;

11. The following Article shall be inserted:

‘Article 12a

Reprocessing of medical devices

The Commission shall, no later than 5 September 2010,submit a report to the European Parliament and to theCouncil on the issue of the reprocessing of medical devicesin the Community.

In the light of the findings of this report, the Commissionshall submit to the European Parliament and to the Councilany additional proposal it may deem appropriate in orderto ensure a high level of health protection.’



‘Article 13

Decisions with regard to classification and derogationclause

1. A Member State shall submit a duly substantiatedrequest to the Commission and ask it to take the necessarymeasures in the following situations:

(a) that Member State considers that the application ofthe classification rules set out in Annex IX requires adecision with regard to the classification of a givendevice or category of devices;

(b) that Member State considers that a given device orfamily of devices should, by way of derogation fromthe provisions of Annex IX, be classified in anotherclass;

(c) that Member State considers that the conformity of adevice or family of devices should, by way ofderogation from Article 11, be established byapplying solely one of the given procedures chosenfrom among those referred to in Article 11;

(d) that Member State considers that a decision is requiredas to whether a particular product or product groupfalls within one of the definitions in Article 1(2)(a) to(e).

The measures referred to in the first subparagraph of thisparagraph shall, as appropriate, be adopted in accordancewith the procedure referred to in Article 7(2).

2. The Commission shall inform the Member States of themeasures taken.’;


(a) in the second subparagraph of paragraph 1, the words‘Classes IIb and III’ shall be replaced by the words‘Classes IIa, IIb and III’;


‘2. Where a manufacturer who places a device onthe market under his own name does not have aregistered place of business in a Member State, he shalldesignate a single authorised representative in theEuropean Union. For devices referred to in the firstsubparagraph of paragraph 1, the authorised repre-sentative shall inform the competent authority of theMember State in which he has his registered place ofbusiness of the details referred to in paragraph 1.’;


‘3. The Member States shall on request inform theother Member States and the Commission of thedetails referred to in the first subparagraph ofparagraph 1 given by the manufacturer or authorisedrepresentative.’;

14. Article 14a shall be amended as follows:

(a) the second subparagraph of paragraph 1 shall beamended as follows:


‘(a) data relating to registration of manufac-turers and authorised representatives anddevices in accordance with Article 14excluding data related to custom-madedevices;’;

(ii) the following point shall be added:

‘(d) data relating to clinical investigationsreferred to in Article 15;’;


‘3. The measures necessary for the implementationof paragraphs 1 and 2 of this Article, in particularparagraph 1(d), shall be adopted in accordance withthe regulatory procedure referred to in Article 7(2).’


‘4. The provisions of this Article shall be imple-mented no later than 5 September 2012. TheCommission shall, no later than 11 October 2012,evaluate the operational functioning and the addedvalue of the databank. On the basis of this evaluation,the Commission shall, if appropriate, present propo-sals to the European Parliament and the Council orpresent draft measures in accordance with para-graph 3.’;

15. Article 14b shall be replaced by the following:

‘Article 14b

Particular health monitoring measures

Where a Member State considers, in relation to a givenproduct or group of products, that, in order to ensureprotection of health and safety and/or to ensure that publichealth requirements are observed, such products should bewithdrawn from the market, or their placing on the marketand putting into service should be prohibited, restricted orsubjected to particular requirements, it may take anynecessary and justified transitional measures.

The Member State shall then inform the Commission andall other Member States, giving the reasons for its decision.

The Commission shall, whenever possible, consult theinterested Parties and the Member States.

The Commission shall adopt its opinion, indicatingwhether the national measures are justified or not. TheCommission shall inform all the Member States and theconsulted interested Parties thereof.


When appropriate, the necessary measures designed toamend non-essential elements of this Directive, relating towithdrawal from the market, prohibition of placing on themarket and putting into service of a certain product orgroup of products or to restrictions or introduction ofparticular requirements in order for such products to be puton the market, shall be adopted in accordance with theregulatory procedure with scrutiny referred to in Article 7(3). On imperative grounds of urgency, the Commissionmay use the urgency procedure referred to in Article 7(4).’;


(a) paragraphs 1, 2 and 3 shall be replaced by thefollowing:

‘1. In the case of devices intended for clinicalinvestigations, the manufacturer or the authorisedrepresentative, established in the Community, shallfollow the procedure referred to in Annex VIII andnotify the competent authorities of the Member Statesin which the investigations are to be conducted bymeans of the statement mentioned in Section 2.2 ofAnnex VIII.

2. In the case of devices falling within Class III andimplantable and long-term invasive devices fallingwithin Class IIa or IIb, the manufacturer maycommence the relevant clinical investigation at theend of a period of 60 days after notification, unlessthe competent authorities have notified him withinthat period of a decision to the contrary based onconsiderations of public health or public policy.

Member States may however authorise manufacturersto commence the relevant clinical investigationsbefore the expiry of the period of 60 days, insofaras the relevant ethics committee has issued afavourable opinion on the programme of investigationin question, including its review of the clinicalinvestigation plan.

3. In the case of devices other than those referred toin paragraph 2, Member States may authorisemanufacturers to commence clinical investigationsimmediately after the date of notification, providedthat the ethics committee concerned has issued afavourable opinion on the programme of investigationin question including its review of the clinicalinvestigation plan.’;

(b) paragraphs 5, 6 and 7 shall be replaced by thefollowing:

‘5. The clinical investigations must be conducted inaccordance with the provisions of Annex X. Themeasures designed to amend non-essential elementsof this Directive, inter alia by supplementing it,relating to the provisions on clinical investigation inAnnex X shall be adopted in accordance with theregulatory procedure with scrutiny referred to inArticle 7(3).

6. The Member States shall, if necessary, take theappropriate steps to ensure public health and publicpolicy. Where a clinical investigation is refused or

halted by a Member State, that Member State shallcommunicate its decision and the grounds therefor toall Member States and the Commission. Where aMember State has called for a significant modificationor temporary interruption of a clinical investigation,that Member State shall inform the Member Statesconcerned about its actions and the grounds for theactions taken.

7. The manufacturer or his authorised representativeshall notify the competent authorities of the MemberStates concerned of the end of the clinical investiga-tion, with a justification in case of early termination.In the case of early termination of the clinicalinvestigation on safety grounds this notification shallbe communicated to all Member States and theCommission. The manufacturer or his authorisedrepresentative shall keep the report referred to inSection 2.3.7 of Annex X at the disposal of thecompetent authorities.’;


(a) the following subparagraph shall be added toparagraph 2:

‘When appropriate in the light of technical progress,the detailed measures necessary to ensure a consistentapplication of the criteria set out in Annex XI for thedesignation of bodies by the Member States shall beadopted in accordance with the regulatory procedurereferred to in Article 7(2).’;

(b) in paragraph 4, the words ‘established in theCommunity’ shall be deleted;


‘5. The notified body shall inform its competentauthority about all certificates issued, modified,supplemented, suspended, withdrawn or refused andthe other notified bodies within the scope of thisDirective about certificates suspended, withdrawn orrefused and, on request, about certificates issued. Thenotified body shall also make available, on request, alladditional relevant information.’;

18. in Article 18 point (a) shall be replaced by the following:

‘(a) where a Member State establishes that the CE markinghas been affixed unduly or is missing in violation ofthe Directive, the manufacturer or his authorisedrepresentative shall be obliged to end the infringementunder conditions imposed by the Member State;’;

19. in Article 19(2), the words ‘established in the Community’shall be deleted;


‘Article 20

Confidentiality

1. Without prejudice to the existing national provisionsand practices on medical confidentiality, Member Statesshall ensure that all the Parties involved in the application


of this Directive are bound to observe confidentiality withregard to all information obtained in carrying out theirtasks.

This does not affect the obligation of Member States andnotified bodies with regard to mutual information and thedissemination of warnings, nor the obligations of thepersons concerned to provide information under criminallaw.

2. The following information shall not be treated asconfidential:

(a) information on the registration of persons responsiblefor placing devices on the market in accordance withArticle 14;

(b) information to users sent out by the manufacturer,authorised representative or distributor in relation to ameasure according to Article 10(3);

(c) information contained in certificates issued, modified,supplemented, suspended or withdrawn.

3. The measures designed to amend non-essentialelements of this Directive, inter alia by supplementing it,relating to determination of the conditions under whichother information may be made publicly available, and inparticular for Class IIb and Class III devices to anyobligation for manufacturers to prepare and make availablea summary of the information and data related to thedevice, shall be adopted in accordance with the regulatoryprocedure with scrutiny referred to in Article 7(3).’;

21. the following Article shall be inserted:

‘Article 20a

Cooperation

Member States shall take appropriate measures to ensurethat the competent authorities of the Member Statescooperate with each other and with the Commission andtransmit to each other the information necessary to enablethis Directive to be applied uniformly.

The Commission shall provide for the organisation of anexchange of experience between the competent authoritiesresponsible for market surveillance in order to coordinatethe uniform application of this Directive.

Without prejudice to the provisions of this Directive,cooperation may be part of initiatives developed at aninternational level.’;

22. Annexes I to X shall be amended in accordance withAnnex II to this Directive.

Article 3

In Article 1(2) of Directive 98/8/EC the following point shall beadded:

‘(s) Directive 98/79/EC of the European Parliament and of theCouncil of 27 October 1998 on in vitro diagnostic medicaldevices (*).

(*) OJ L 331, 7.12.1998, p. 1. Directive as last amended byRegulation (EC) No 1882/2003 (OJ L 284, 31.10.2003,p. 1).’

Article 4

1. Member States shall adopt and publish by 21 December2008 the laws, regulations and administrative provisionsnecessary to comply with this Directive. They shall forthwithcommunicate to the Commission the text of those measures.

They shall apply those measures from 21 March 2010.

When Member States adopt those measures, they shall contain areference to this Directive or be accompanied by such a referenceon the occasion of their official publication. The methods ofmaking such reference shall be laid down by Member States.

2. Member States shall communicate to the Commission thetext of the main provisions of national law which they adopt inthe field covered by this Directive.

Article 5

This Directive shall enter into force on the 20th day following itspublication in the Official Journal of the European Union.

Article 6

This Directive is addressed to the Member States.

Done at Strasbourg, 5 September 2007.

For the European Parliament

The President

H.-G. PÖTTERING

For the Council

The President

M. LOBO ANTUNES


ANNEX I

Annexes 1 to 7 to Directive 90/385/EEC shall be amended as follows:

1. Annex 1 shall be amended as follows:

(a) the following Section shall be inserted:

‘5a. Demonstration of conformity with the essential requirements must include a clinical evaluation inaccordance with Annex 7.’;

(b) in Section 8, the fifth indent shall be replaced by the following:

‘— risks connected with ionising radiation from radioactive substances included in the device, in compliancewith the protection requirements laid down in Council Directive 96/29/Euratom of 13 May 1996 layingdown basic safety standards for the protection of the health of workers and the general public against thedangers arising from ionising radiation (*) and Council Directive 97/43/Euratom of 30 June 1997 onhealth protection of individuals against the dangers of ionising radiation in relation to medical expo-sure (**).

(*) OJ L 159, 29.6.1996, p. 1.(**) OJ L 180, 9.7.1997, p. 22.’;

(c) in Section 9, seventh indent, the following phrase shall be added:

‘For devices which incorporate software or which are medical software in themselves, the software must bevalidated according to the state of the art taking into account the principles of development lifecycle, riskmanagement, validation and verification.’;

(d) Section 10 shall be replaced by the following:

‘10. Where a device incorporates, as an integral part, a substance which, if used separately, may be consideredto be a medicinal product as defined in Article 1 of Directive 2001/83/EC, and which is liable to act uponthe body with action ancillary to that of the device, the quality, safety and usefulness of the substancemust be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.

For the substances referred to in the first paragraph, the notified body shall, having verified the usefulnessof the substance as part of the medical device and taking account of the intended purpose of the device,seek a scientific opinion from one of the competent authorities designated by the Member States or theEuropean Medicines Agency (EMEA) acting particularly through its committee in accordance withRegulation (EC) No 726/2004 (*) on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competentauthority or the EMEA shall take into account the manufacturing process and the data related to theusefulness of incorporation of the substance into the device as determined by the notified body.

Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, havingverified the usefulness of the substance as part of the device and taking account of the intended purposeof the device, seek a scientific opinion from the EMEA, acting particularly through its committee, on thequality and safety of the substance, including the clinical benefit/risk profile of the incorporation of thehuman blood derivative into the device. When issuing its opinion, the EMEA shall take into account themanufacturing process and the data related to the usefulness of incorporation of the substance into thedevice as determined by the notified body.

Where changes are made to an ancillary substance incorporated in a device, in particular related to itsmanufacturing process, the notified body shall be informed of the changes and shall consult the relevantmedicines competent authority (i.e. the one involved in the initial consultation), in order to confirm thatthe quality and safety of the ancillary substance are maintained. The competent authority shall take intoaccount the data related to the usefulness of the incorporation of the substance into the device asdetermined by the notified body, in order to ensure that the changes have no negative impact on theestablished benefit/risk profile of the addition of the substance in the device.

When the relevant medicines competent authority (i.e. the one involved in the initial consultation) hasobtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance to the device, it shall provide the notified body with advice,


whether this information has an impact on the established benefit/risk profile of the addition of thesubstance to the device or not. The notified body shall take the updated scientific opinion into account inreconsidering its assessment of the conformity assessment procedure.

(*) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 layingdown Community procedures for the authorisation and supervision of medicinal products for human andveterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation aslast amended by Regulation (EC) No 1901/2006.’;

(e) Section 14.2 shall be amended as follows:

(i) the first indent shall be replaced by the following:

‘— the name and address of the manufacturer and the name and address of the authorisedrepresentative, where the manufacturer does not have a registered place of business in theCommunity,’;

(ii) the following indent shall be added:

‘— in the case of a device within the meaning of Article 1(4a), an indication that the device contains ahuman blood derivative.’;

(f) the following indent shall be added to the second paragraph of Section 15:

‘— date of issue or the latest revision of the instructions for use.’;


(a) in Section 2, the third paragraph shall be replaced by the following:

‘This declaration shall cover one or more clearly identified devices by means of product name, product code orother unambiguous reference and must be kept by the manufacturer.’;

(b) in the second paragraph of Section 3.1, the first sentence of the fifth indent shall be replaced by the following:

‘— an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance systemincluding the provisions referred to in Annex 7.’;

(c) Section 3.2 shall be amended as follows:

(i) the following sentence shall be added to the second subparagraph:

‘It shall include in particular the corresponding documentation, data and records arising from theprocedures referred to in point (c).’;

(ii) the following indent shall be added to point (b):

‘— where the design, manufacture and/or final inspection and testing of the products, or elementsthereof, is carried out by a third party, the methods of monitoring the efficient operation of thequality system and in particular the type and extent of control applied to the third party.’;

(iii) the following indents shall be added to point (c):

‘— a statement indicating whether or not the device incorporates, as an integral part, a substance or ahuman blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted inthis connection required to assess the safety, quality and usefulness of that substance or humanblood derivative, taking account of the intended purpose of the device,


— the clinical evaluation referred to in Annex 7.’;


(d) in Section 3.3, the last sentence of the second subparagraph shall be replaced by the following:

‘The evaluation procedure shall include an inspection on the manufacturer's premises and, in duly substantiatedcases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect the manufacturingprocesses.’;

(e) Section 4.2 shall be amended as follows:

(i) the first paragraph shall be replaced by the following:

‘The application shall describe the design, manufacture and performances of the product in question, andit must include the documents needed to assess whether the product conforms to the requirements of thisDirective, and in particular Annex 2, Section 3.2, third paragraph, points (c) and (d).’;

(ii) in the fourth indent of the second paragraph, the word ‘data’ shall be replaced by the word ‘evaluation’;

(f) in Section 4.3, the following paragraphs shall be added:

‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regardsthe aspects referred to in that section, consult one of the competent authorities designated by the Member Statesin accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competentnational authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. Thescientific opinion of the competent national authority or the EMEA must be included in the documentationconcerning the device. The notified body will give due consideration to the views expressed in this consultationwhen making its decision. It will convey its final decision to the competent body concerned.

In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEAmust be included in the documentation concerning the device. The opinion shall be drawn up within 210 daysafter receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEAwhen making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion isunfavourable. It will convey its final decision to the EMEA.’;

(g) in Section 5.2, the second indent shall be replaced by the following:

‘— the data stipulated in the part of the quality system relating to design, such as the results of analyses,calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the resultsof the post-market clinical follow-up, if applicable, etc.’;

(h) Section 6.1 shall be replaced by the following:

‘6.1. For at least 15 years from the last date of manufacture of the product, the manufacturer or his authorisedrepresentative shall keep available for the national authorities:


— the documentation referred to in the second indent of Section 3.1, and in particular thedocumentation, data and records referred to in the second paragraph of Section 3.2,

— the amendments referred to in Section 3.4,

— the documentation referred to in Section 4.2,

— the decisions and reports of the notified body referred to in Sections 3.4, 4.3, 5.3 and 5.4.’;

(i) Section 6.3 shall be deleted;

(j) the following Section shall be added:

‘7. Application to the devices referred to in Article 1(4a):

Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturershall inform the notified body of the release of the batch of devices and send to it the official certificate


concerning the release of the batch of human blood derivative used in the device, issued by a Statelaboratory or a laboratory designated for that purpose by a Member State in accordance with Art-icle 114(2) of Directive 2001/83/EC.’;


(a) Section 3 shall be amended as follows:


‘— a general description of the type, including any variants planned, and its intended use(s),’;

(ii) the fifth to eighth indents shall be replaced by the following:

‘— the results of design calculations, risk analysis, investigations and technical tests carried out, etc.,

— a declaration stating whether or not the device incorporates, as an integral part, a substance or ahuman blood derivative as referred to in Section 10 of Annex 1 and the data on the tests conductedin this connection required to assess the safety, quality and usefulness of that substance or humanblood derivative, taking account of the intended purpose of the device,


— the clinical evaluation referred to in Annex 7,

— the draft instruction leaflet.’;

(b) the following paragraphs shall be added to Section 5:

‘In the case of devices referred to in Annex 1, Section 10, second paragraph, the notified body shall, as regardsthe aspects referred to in that section, consult one of the competent authorities designated by the Member Statesin accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competentnational authority or the EMEA shall be drawn up within 210 days after receipt of valid documentation. Thescientific opinion of the competent national authority or the EMEA must be included in the documentationconcerning the device. The notified body will give due consideration to the views expressed in this consultationwhen making its decision. It will convey its final decision to the competent body concerned.

In the case of devices referred to in Annex 1, Section 10, third paragraph, the scientific opinion of the EMEAmust be included in the documentation concerning the device. The opinion shall be drawn up within 210 daysafter receipt of valid documentation. The notified body will give due consideration to the opinion of the EMEAwhen making its decision. The notified body may not deliver the certificate if the EMEA's scientific opinion isunfavourable. It will convey its final decision to the EMEA.’;

(c) in Section 7.3, the words ‘five years from the manufacture of the last appliance’ shall be replaced by the words‘15 years from the manufacture of the last product’;

(d) Section 7.4 shall be deleted;


(a) in Section 4, the words ‘post-marketing surveillance system’ shall be replaced by the words ‘post-marketingsurveillance system including the provisions referred to in Annex 7’;

(b) Section 6.3 shall be replaced by the following:

‘6.3. Statistical control of products will be based on attributes and/or variables, entailing sampling schemeswith operational characteristics which ensure a high level of safety and performance according to the stateof the art. The sampling schemes will be established by the harmonised standards referred to in Article 5,taking account of the specific nature of the product categories in question.’;


(c) the following Section shall be added:


Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturershall inform the notified body of the release of the batch of devices and send to it the official certificateconcerning the release of the batch of human blood derivative used in the device, issued by a Statelaboratory or a laboratory designated for that purpose by a Member State in accordance with Art-icle 114(2) of Directive 2001/83/EC.’;


(a) in Section 2, second paragraph, the words ‘identified specimens of the product and shall be kept by themanufacturer’ shall be replaced by the words ‘devices manufactured, clearly identified by means of productname, product code or other unambiguous reference and must be kept by the manufacturer ’;

(b) in the sixth indent of Section 3.1, the words ‘post-marketing surveillance system’ shall be replaced by the words‘post-marketing surveillance system including the provisions referred to in Annex 7’;

(c) in Section 3.2(b), the following indent shall be added:

‘— where the manufacture and/or final inspection and testing of the products, or elements thereof, are carriedout by a third party, the methods of monitoring the efficient operation of the quality system and inparticular the type and extent of control applied to the third party.’;

(d) in Section 4.2, the following indent shall be inserted after the first indent:

‘— the technical documentation,’;

(e) the following Section shall be added:


Upon completing the manufacture of each batch of devices referred to in Article 1(4a), the manufacturershall inform the notified body of the release of the batch of devices and send to it the official certificateconcerning the release of the batch of human blood derivative used in the device, issued by a Statelaboratory or a laboratory designated for that purpose by a Member State in accordance with Art-icle 114(2) of Directive 2001/83/EC.’;


(a) Section 2.1 shall be amended as follows:

(i) the first indent shall be replaced by the following two indents:

‘— the name and address of the manufacturer,

— the information necessary for the identification of the product in question,’;

(ii) in the third indent, the word ‘doctor’ shall be replaced by the words ‘duly qualified medical practitioner ’;

(iii) the fourth indent shall be replaced by the following:

‘— the specific characteristics of the product revealed by the prescription,’;

(b) Section 2.2 shall be replaced by the following:

‘2.2. For devices intended for clinical investigations covered in Annex 7:

— data allowing the devices in question to be identified,

— the clinical investigation plan,


— the investigator's brochure,



— a statement indicating whether or not the device incorporates, as an integral part, a substance orhuman blood derivative referred to in Section 10 of Annex 1,

— the opinion of the ethics committee concerned and details of the aspects covered by its opinion,

— the name of the duly qualified medical practitioner or other authorised person and of the institutionresponsible for the investigations,

— the place, date of commencement and duration scheduled for the investigations,

— a statement affirming that the device in question complies with the essential requirements apartfrom the aspects constituting the object of the investigations and that, with regard to these aspects,every precaution has been taken to protect the health and safety of the patient.’;

(c) in Section 3.1, the first paragraph shall be replaced by the following:

‘For custom-made devices, documentation, indicating manufacturing site(s) and enabling the design,manufacture and performances of the product, including the expected performances, to be understood, so asto allow conformity with the requirements of this Directive to be assessed.’;

(d) in Section 3.2, the first paragraph shall be amended as follows:


‘— a general description of the product and its intended use,’;

(ii) in the fourth indent, the words ‘a list of the standards’ shall be replaced by the words ‘the results of the riskanalysis and a list of the standards’;

(iii) the following indent shall be inserted after the fourth indent:

‘— if the device incorporates, as an integral part, a substance or human blood derivative referred to inSection 10 of Annex 1, the data on the tests conducted in this connection which are required toassess the safety, quality and usefulness of that substance, or human blood derivative, taking accountof the intended purpose of the device,’;

(e) the following two sections shall be added:

‘4. The information included in the declarations covered by this Annex shall be kept for a period of at least15 years from the date of manufacture of the last product.

5. For custom-made devices, the manufacturer must undertake to review and to document experience gainedin the post-production phase, including the provisions referred to in Annex 7, and to implementappropriate means to apply any necessary corrective action. This undertaking must include an obligationfor the manufacturer to notify the competent authorities of the following incidents immediately onlearning of them and the relevant corrective actions:

(i) any malfunction or deterioration in the characteristics and/or performance of a device, as well asany inadequacy in the labelling or the instructions for use which might lead to or might have led tothe death of a patient or user or to a serious deterioration in his state of health;

(ii) any technical or medical reason connected with the characteristics or performance of a device forthe reasons referred to in point (i) leading to systematic recall of devices of the same type by themanufacturer.’;



(a) Section 1 shall be replaced by the following:

‘1. General provisions

1.1. As a general rule, confirmation of conformity with the requirements concerning the characteristics andperformances referred to in Sections 1 and 2 of Annex 1 under the normal conditions of use of thedevice and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to inSection 5 of Annex 1, must be based on clinical data. The evaluation of this data (hereinafter referred toas clinical evaluation), where appropriate taking account of any relevant harmonised standards, mustfollow a defined and methodologically sound procedure based on:

1.1.1. Either a critical evaluation of the relevant scientific literature currently available relating to the safety,performance, design characteristics and intended purpose of the device where:

— there is demonstration of equivalence of the device to the device to which the data relates and,

— the data adequately demonstrate compliance with the relevant essential requirements;

1.1.2. Or a critical evaluation of the results of all the clinical investigations made,

1.1.3. Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.

1.2. Clinical investigations shall be performed unless it is duly justified to rely on existing clinical data.

1.3. The clinical evaluation and its outcome shall be documented. This documentation shall be includedand/or fully referenced in the technical documentation of the device.

1.4. The clinical evaluation and its documentation must be actively updated with data obtained from thepost-market surveillance. Where post-market clinical follow-up as part of the post-market surveillanceplan for the device is not deemed necessary, this must be duly justified and documented.

1.5. Where demonstration of conformity with essential requirements based on clinical data is not deemedappropriate, adequate justification for any such exclusion has to be given based on risk managementoutput and under consideration of the specifics of the device/body interaction, the clinical performancesintended and the claims of the manufacturer. Adequacy of demonstration of conformity with theessential requirements by performance evaluation, bench testing and pre-clinical evaluation alone has tobe duly substantiated.

1.6. All data must remain confidential unless it is deemed essential that they be divulged.’

(b) Section 2.3.5 shall be replaced by the following:

‘2.3.5. All serious adverse events must be fully recorded and immediately notified to all competent authorities ofthe Member States in which the clinical investigation is being performed.’

(c) In Section 2.3.6, the words ‘appropriately qualified medical specialist’ shall be replaced by the words ‘dulyqualified medical practitioner or authorised person’.


ANNEX II

Annexes I to X to Directive 93/42/EEC shall be amended as follows:

1. Annex I shall be amended as follows:


‘1. The devices must be designed and manufactured in such a way that, when used under the conditions andfor the purposes intended, they will not compromise the clinical condition or the safety of patients, or thesafety and health of users or, where applicable, other persons, provided that any risks which may beassociated with their intended use constitute acceptable risks when weighed against the benefits to thepatient and are compatible with a high level of protection of health and safety.

This shall include:

— reducing, as far as possible, the risk of use error due to the ergonomic features of the device and theenvironment in which the device is intended to be used (design for patient safety), and

— consideration of the technical knowledge, experience, education and training and where applicablethe medical and physical conditions of intended users (design for lay, professional, disabled or otherusers).’;

(b) the following Section shall be inserted:

‘6a. Demonstration of conformity with the essential requirements must include a clinical evaluation inaccordance with Annex X.’;

(c) in Section 7.1, the following indent shall be added:

‘— where appropriate, the results of biophysical or modelling research whose validity has been demonstratedbeforehand.’;

(d) Section 7.4. shall be replaced by the following:

‘7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may be consideredto be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is liable to act uponthe body with action ancillary to that of the device, the quality, safety and usefulness of the substancemust be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC.

For the substances referred to in the first paragraph, the notified body shall, having verified the usefulnessof the substance as part of the medical device and taking account of the intended purpose of the device,seek a scientific opinion from one of the competent authorities designated by the Member States or theEuropean Medicines Agency (EMEA) acting particularly through its committee in accordance withRegulation (EC) No 726/2004 (*) on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device. When issuing its opinion, the competentauthority or the EMEA shall take into account the manufacturing process and the data related to theusefulness of incorporation of the substance into the device as determined by the notified body.

Where a device incorporates, as an integral part, a human blood derivative, the notified body shall, havingverified the usefulness of the substance as part of the medical device and taking into account the intendedpurpose of the device, seek a scientific opinion from the EMEA, acting particularly through its committee,on the quality and safety of the substance including the clinical benefit/risk profile of the incorporation ofthe human blood derivative into the device. When issuing its opinion, the EMEA shall take into accountthe manufacturing process and the data related to the usefulness of incorporation of the substance intothe device as determined by the notified body.

Where changes are made to an ancillary substance incorporated in a device, in particular related to itsmanufacturing process, the notified body shall be informed of the changes and shall consult the relevantmedicines competent authority (i.e. the one involved in the initial consultation), in order to confirm thatthe quality and safety of the ancillary substance are maintained. The competent authority shall take into


account the data related to the usefulness of incorporation of the substance into the device as determinedby the notified body, in order to ensure that the changes have no negative impact on the establishedbenefit/risk profile of the addition of the substance in the medical device.

When the relevant medicines competent authority (i.e. the one involved in the initial consultation) hasobtained information on the ancillary substance, which could have an impact on the established benefit/risk profile of the addition of the substance in the medical device, it shall provide the notified body withadvice, whether this information has an impact on the established benefit/risk profile of the addition ofthe substance in the medical device or not. The notified body shall take the updated scientific opinion intoaccount in reconsidering its assessment of the conformity assessment procedure.

(*) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 layingdown Community procedures for the authorisation and supervision of medicinal products for human andveterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). Regulation aslast amended by Regulation (EC) No 1901/2006.’

(e) Section 7.5 shall be replaced by the following:

‘7.5. The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posedby substances leaking from the device. Special attention shall be given to substances which arecarcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisionsrelating to the classification, packaging and labelling of dangerous substances (*).

If parts of a device (or a device itself) intended to administer and/or remove medicines, body liquids orother substances to or from the body, or devices intended for transport and storage of such body fluids orsubstances, contain phthalates which are classified as carcinogenic, mutagenic or toxic to reproduction, ofcategory 1 or 2, in accordance with Annex I to Directive 67/548/EEC, these devices must be labelled onthe device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging as adevice containing phthalates.

If the intended use of such devices includes treatment of children or treatment of pregnant or nursingwomen, the manufacturer must provide a specific justification for the use of these substances with regardto compliance with the essential requirements, in particular of this paragraph, within the technicaldocumentation and, within the instructions for use, information on residual risks for these patient groupsand, if applicable, on appropriate precautionary measures.

(*) OJ 196, 16.8.1967, p. 1. Directive as last amended by Directive 2006/121/EC of the EuropeanParliament and of the Council (OJ L 396, 30.12.2006, p. 850).’

(f) in Section 8.2, the word ‘transferable’ shall be replaced by the word ‘transmissible’;

(g) the following Section shall be inserted:

‘12.1a For devices which incorporate software or which are medical software in themselves, the software mustbe validated according to the state of the art taking into account the principles of development lifecycle,risk management, validation and verification.’;

(h) in Section 13.1, the first paragraph shall be replaced by the following:

‘13.1. Each device must be accompanied by the information needed to use it safely and properly, taking accountof the training and knowledge of the potential users, and to identify the manufacturer.’;

(i) Section 13.3 shall be amended as follows:


‘(a) the name or trade name and address of the manufacturer. For devices imported into theCommunity, in view of their distribution in the Community, the label, or the outer packaging, orinstructions for use, shall contain in addition the name and address of the authorised representativewhere the manufacturer does not have a registered place of business in the Community;’


(ii) point (b) shall be replaced by the following:

‘(b) the details strictly necessary to identify the device and the contents of the packaging especially forthe users;’

(iii) point (f) shall be replaced by the following:

‘(f) where appropriate, an indication that the device is for single use. A manufacturer's indication ofsingle use must be consistent across the Community;’

(j) Section 13.6 shall be amended as follows:

(i) the following subparagraph shall be added to point (h):

‘If the device bears an indication that the device is for single use, information on known characteristics andtechnical factors known to the manufacturer that could pose a risk if the device were to be re-used. If inaccordance with Section 13.1 no instructions for use are needed, the information must be made availableto the user upon request;’

(ii) point (o) shall be replaced by the following:

‘(o) medicinal substances, or human blood derivatives incorporated into the device as an integral part inaccordance with Section 7.4;’

(iii) the following point shall be added:

‘(q) date of issue or the latest revision of the instructions for use.’;

(k) Section 14 shall be deleted.

2. Annex II shall be amended as follows:


‘2. The EC declaration of conformity is the procedure whereby the manufacturer who fulfils the obligationsimposed by Section 1 ensures and declares that the products concerned meet the provisions of thisDirective which apply to them.

The manufacturer must affix the CE marking in accordance with Article 17 and draw up a writtendeclaration of conformity. This declaration must cover one or more medical devices manufactured, clearlyidentified by means of product name, product code or other unambiguous reference and must be kept bythe manufacturer.’;

(b) in Section 3.1, second paragraph, the introductory part of the seventh indent shall be replaced by the following:

‘— an undertaking by the manufacturer to institute and keep up to date a systematic procedure to reviewexperience gained from devices in the post-production phase, including the provisions referred to inAnnex X, and to implement appropriate means to apply any necessary corrective action. This undertakingmust include an obligation for the manufacturer to notify the competent authorities of the followingincidents immediately on learning of them:’;


(i) the following paragraph shall be inserted after the first paragraph:

‘It shall include in particular the corresponding documentation, data and records arising from theprocedures referred to in point (c).’;

(ii) in point (b), the following indent shall be added:

‘— where the design, manufacture and/or final inspection and testing of the products, or elementsthereof, is carried out by a third party, the methods of monitoring the efficient operation of thequality system and in particular the type and extent of control applied to the third party;’


(iii) point (c) shall be replaced by the following:

‘(c) the procedures for monitoring and verifying the design of the products, including thecorresponding documentation, and in particular:

— a general description of the product, including any variants planned, and its intended use(s),

— the design specifications, including the standards which will be applied and the results of therisk analysis, and also a description of the solutions adopted to fulfil the essentialrequirements which apply to the products if the standards referred to in Article 5 are notapplied in full,

— the techniques used to control and verify the design and the processes and systematicmeasures which will be used when the products are being designed,

— if the device is to be connected to other device(s) in order to operate as intended, proof mustbe provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,

— a statement indicating whether or not the device incorporates, as an integral part, a substanceor a human blood derivative referred to in section 7.4 of Annex I and the data on the testsconducted in this connection required to assess the safety, quality and usefulness of thatsubstance or human blood derivative, taking account of the intended purpose of the device,

— a statement indicating whether or not the device is manufactured utilising tissues of animalorigin as referred to in Commission Directive 2003/32/EC (*),





(*) Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regardsthe requirements laid down in Council Directive 93/42/EEC with respect to medical devicesmanufactured utilising tissues of animal origin (OJ L 105, 26.4.2003, p. 18).’

(d) the second paragraph of Section 3.3 shall be replaced by the following:

‘The assessment team must include at least one member with past experience of assessments of the technologyconcerned. The assessment procedure must include an assessment, on a representative basis, of thedocumentation of the design of the product(s) concerned, an inspection on the manufacturer's premises and, induly substantiated cases, on the premises of the manufacturer's suppliers and/or subcontractors to inspect themanufacturing processes.’;

(e) in Section 4.3, the second and third paragraphs shall be replaced by the following:

‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regardsthe aspects referred to in that section, consult one of the competent authorities designated by the Member Statesin accordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competentnational authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. Thescientific opinion of the competent national authority or the EMEA must be included in the documentationconcerning the device. The notified body will give due consideration to the views expressed in this consultationwhen making its decision. It will convey its final decision to the competent body concerned.

In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEAmust be included in the documentation concerning the device. The opinion of the EMEA must be drawn upwithin 210 days after receipt of valid documentation. The notified body will give due consideration to theopinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA'sscientific opinion is unfavourable. It will convey its final decision to the EMEA.


In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, thenotified body must follow the procedures referred to in that Directive.’;

(f) in Section 5.2, the second indent shall be replaced by the following:

‘— the data stipulated in the part of the quality system relating to design, such as the results of analyses,calculations, tests, the solutions adopted as referred to in Annex I, Chapter I, Section 2, pre-clinical andclinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,’;

(g) Section 6.1 shall be amended as follows:

(i) the introductory part shall be replaced by the following:

‘The manufacturer or his authorised representative must, for a period ending at least five years, and in thecase of implantable devices at least 15 years, after the last product has been manufactured, keep at thedisposal of the national authorities:’;

(ii) the following phrase shall be added to the second indent:

‘and in particular the documentation, data and records referred to in the second paragraph of Section 3.2,’;

(h) Section 6.3 shall be deleted;

(i) Section 7 shall be replaced by the following:

‘7. Application to devices in Classes IIa and IIb.

7.1. In line with Article 11(2) and (3), this Annex may apply to products in Classes IIa and IIb. Section 4,however, does not apply.

7.2. For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technicaldocumentation as described in Section 3.2(c) for at least one representative sample for each devicesubcategory for compliance with the provisions of this Directive.

7.3. For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, thetechnical documentation as described in Section 3.2(c) for at least one representative sample for eachgeneric device group for compliance with the provisions of this Directive.

7.4. In choosing representative sample(s) the notified body shall take into account the novelty of thetechnology, similarities in design, technology, manufacturing and sterilisation methods, the intended useand the results of any previous relevant assessments (e.g. with regard to physical, chemical or biologicalproperties) that have been carried out in accordance with this Directive. The notified body shall documentand keep available to the competent authority its rationale for the sample(s) taken.

7.5. Further samples shall be assessed by the notified body as part of the surveillance assessment referred to inSection 5.’;

(j) in Section 8, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) ofDirective 2001/83/EC’;

3. Annex III shall be amended as follows:


‘3. The documentation must allow an understanding of the design, the manufacture and the performances ofthe product and must contain the following items in particular:

— a general description of the type, including any variants planned, and its intended use(s),

— design drawings, methods of manufacture envisaged, in particular as regards sterilisation, anddiagrams of components, sub-assemblies, circuits, etc.,


— the descriptions and explanations necessary to understand the abovementioned drawings anddiagrams and the operation of the product,

— a list of the standards referred to in Article 5, applied in full or in part, and descriptions of thesolutions adopted to meet the essential requirements if the standards referred to in Article 5 havenot been applied in full,

— the results of the design calculations, risk analysis, investigations, technical tests, etc. carried out,

— a statement indicating whether or not the device incorporates, as an integral part, a substance, orhuman blood derivative, referred to in Section 7.4 of Annex I, and the data on the tests conductedin this connection which are required to assess the safety, quality and usefulness of that substance,or human blood derivative, taking account of the intended purpose of the device,

— a statement indicating whether or not the device is manufactured utilising tissues of animal origin asreferred to in Directive 2003/32/EC,




— the draft label and, where appropriate, instructions for use.’;

(b) in Section 5, the second and third paragraphs shall be replaced by the following:

‘In the case of devices referred to in Annex I, Section 7.4, second paragraph, the notified body shall, as regardsthe aspects referred to in that section, consult one of the authorities designated by the Member States inaccordance with Directive 2001/83/EC or the EMEA before taking a decision. The opinion of the competentnational authority or the EMEA must be drawn up within 210 days after receipt of valid documentation. Thescientific opinion of the competent national authority or the EMEA must be included in the documentationconcerning the device. The notified body will give due consideration to the views expressed in this consultationwhen making its decision. It will convey its final decision to the competent body concerned.

In the case of devices referred to in Annex I, Section 7.4, third paragraph, the scientific opinion of the EMEAmust be included in the documentation concerning the device. The opinion of the EMEA must be drawn upwithin 210 days after receipt of valid documentation. The notified body will give due consideration to theopinion of the EMEA when making its decision. The notified body may not deliver the certificate if the EMEA'sscientific opinion is unfavourable. It will convey its final decision to the EMEA.

In the case of devices manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, thenotified body must follow the procedures referred to in that Directive.’;

(c) Section 7.3 shall be replaced by the following:

‘7.3. The manufacturer or his authorised representative must keep with the technical documentation copies ofEC type-examination certificates and their additions for a period ending at least five years after the lastdevice has been manufactured. In the case of implantable devices, the period shall be at least 15 years afterthe last product has been manufactured.’;

(d) Section 7.4 shall be deleted;

4. Annex IV shall be amended as follows:

(a) in Section 1, the words ‘established in the Community’ shall be deleted;

(b) in Section 3, the first paragraph shall be replaced by the following:

‘3. The manufacturer must undertake to institute and keep up to date a systematic procedure to reviewexperience gained from devices in the post-production phase, including the provisions referred to in


Annex X, and to implement appropriate means to apply any necessary corrective action. This undertakingmust include an obligation for the manufacturer to notify the competent authorities of the followingincidents immediately on learning of them:’;

(c) Section 6.3 shall be replaced by the following:

‘6.3. Statistical control of products will be based on attributes and/or variables, entailing sampling schemeswith operational characteristics which ensure a high level of safety and performance according to the stateof the art. The sampling schemes will be established by the harmonised standards referred to in Article 5,taking account of the specific nature of the product categories in question.’;

(d) in Section 7, the introductory part shall be replaced by the following:

‘The manufacturer or his authorised representative must, for a period ending at least five years, and in the case ofimplantable devices at least 15 years, after the last product has been manufactured, make available to thenational authorities:’;

(e) in the introductory part of Section 8 the word ‘exemptions’ shall be deleted;

(f) in Section 9, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) ofDirective 2001/83/EC’;

5. Annex V shall be amended as follows:


‘2. The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils theobligations imposed by Section 1 ensures and declares that the products concerned conform to the typedescribed in the EC type-examination certificate and meet the provisions of this Directive which apply tothem.

The manufacturer must affix the CE marking in accordance with Article 17 and draw up a writtendeclaration of conformity. This declaration must cover one or more medical devices manufactured, clearlyidentified by means of product name, product code or other unambiguous reference, and must be kept bythe manufacturer.’;

(b) in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by thefollowing:

‘— an undertaking by the manufacturer to institute and keep up to date a systematic procedure to reviewexperience gained from devices in the post-production phase, including the provisions referred to inAnnex X, and to implement appropriate means to apply any necessary corrective action. This undertakingmust include an obligation for the manufacturer to notify the competent authorities of the followingincidents immediately on learning of them;’;

(c) in point (b) of the third paragraph of Section 3.2, the following indent shall be added:

‘— where the manufacture and/or final inspection and testing of the products, or elements thereof, are carriedout by a third party, the methods of monitoring the efficient operation of the quality system and inparticular the type and extent of control applied to the third party;’

(d) in Section 4.2, the following indent shall be inserted after the first indent:

‘— the technical documentation,’;

(e) in Section 5.1, the introductory part shall be replaced by the following:



(f) Section 6 shall be replaced by the following:

‘6. Application to devices in Class IIa

In line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:

6.1. By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity themanufacturer ensures and declares that the products in Class IIa are manufactured in conformity with thetechnical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directivewhich apply to them.

6.2. For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technicaldocumentation as described in Section 3 of Annex VII for at least one representative sample for eachdevice subcategory for compliance with the provisions of this Directive.


6.4. Further samples shall be assessed by the notified body as part of the surveillance assessment referred to inSection 4.3.’;

(g) in Section 7, the words ‘Article 4(3) of Directive 89/381/EEC’ shall be replaced by the words ‘Article 114(2) ofDirective 2001/83/EC’;

6. Annex VI shall be amended as follows:


‘2. The EC declaration of conformity is the part of the procedure whereby the manufacturer who fulfils theobligations imposed by Section 1 ensures and declares that the products concerned conform to the typedescribed in the EC type-examination certificate and meet the provisions of this Directive which apply tothem.

The manufacturer affixes the CE marking in accordance with Article 17 and draws up a writtendeclaration of conformity. This declaration must cover one or more medical devices manufactured, clearlyidentified by means of product name, product code or other unambiguous reference, and be kept by themanufacturer. The CE marking must be accompanied by the identification number of the notified bodywhich performs the tasks referred to in this Annex.’;

(b) in the eighth indent of the second paragraph of Section 3.1, the introductory part shall be replaced by thefollowing:

‘— an undertaking by the manufacturer to institute and keep up to date a systematic procedure to reviewexperience gained from devices in the post-production phase, including the provisions referred to inAnnex X, and to implement appropriate means to apply any necessary corrective action. This undertakingmust include an obligation for the manufacturer to notify the competent authorities of the followingincidents immediately on learning of them:’;

(c) in Section 3.2, the following indent shall be added:

‘— where the final inspection and testing of the products, or elements thereof, are carried out by a third party,the methods of monitoring the efficient operation of the quality system and in particular the type andextent of control applied to the third party;’

(d) in Section 5.1, the introductory part shall be replaced by the following:



(e) Section 6 shall be replaced by the following:

‘6. Application to devices in Class IIa

In line with Article 11(2), this Annex may apply to products in Class IIa, subject to the following:

6.1. By way of derogation from Sections 2, 3.1 and 3.2, by virtue of the declaration of conformity themanufacturer ensures and declares that the products in Class IIa are manufactured in conformity with thetechnical documentation referred to in Section 3 of Annex VII and meet the requirements of this Directivewhich apply to them.

6.2. For devices in Class IIa the notified body shall assess, as part of the assessment in Section 3.3, the technicaldocumentation as described in Section 3 of Annex VII for at least one representative sample for eachdevice subcategory for compliance with the provisions of this Directive.


6.4. Further samples shall be assessed by the notified body as part of the surveillance assessment referred to inSection 4.3.’;

7. Annex VII shall be amended as follows:

(a) Sections 1 and 2 shall be replaced by the following:

‘1. The EC declaration of conformity is the procedure whereby the manufacturer or his authorisedrepresentative who fulfils the obligations imposed by Section 2 and, in the case of products placed on themarket in a sterile condition and devices with a measuring function, the obligations imposed by Section 5ensures and declares that the products concerned meet the provisions of this Directive which apply tothem.

2. The manufacturer must prepare the technical documentation described in Section 3. The manufacturer orhis authorised representative must make this documentation, including the declaration of conformity,available to the national authorities for inspection purposes for a period ending at least five years after thelast product has been manufactured. In the case of implantable devices the period shall be at least 15 yearsafter the last product has been manufactured.’;

(b) Section 3 shall be amended as follows:


‘— a general description of the product, including any variants planned and its intended use(s),’;

(ii) the fifth indent shall be replaced by the following:

‘— in the case of products placed on the market in a sterile condition, description of the methods usedand the validation report,’;

(iii) the seventh indent shall be replaced by the following indents:

‘— the solutions adopted as referred to in Annex I, Chapter I, Section 2,

— the pre-clinical evaluation,’;

(iv) the following indent shall be inserted after the seventh indent:

‘— the clinical evaluation in accordance with Annex X,’;


(c) in Section 4, the introductory part shall be replaced by the following:

‘4. The manufacturer shall institute and keep up to date a systematic procedure to review experience gainedfrom devices in the post-production phase, including the provisions referred to in Annex X, and toimplement appropriate means to apply any necessary corrective actions, taking account of the nature andrisks in relation to the product. He shall notify the competent authorities of the following incidentsimmediately on learning of them:’;

(d) in Section 5, the words ‘Annex IV, V or VI’ shall be replaced by the words ‘Annex II, IV, V or VI’;

8. Annex VIII shall be amended as follows:

(a) in Section 1, the words ‘established in the Community’ shall be deleted;

(b) Section 2.1 shall be amended as follows:

(i) the following indent shall be inserted after the introductory phrase:

‘— the name and address of the manufacturer,’;

(ii) the fourth indent shall be replaced by the following:

‘— the specific characteristics of the product as indicated by the prescription,’;


(i) the second indent shall be replaced by the following:

‘— the clinical investigation plan,’;

(ii) the following indents shall be inserted after the second indent:

‘— the investigator's brochure,



— a statement indicating whether or not the device incorporates, as an integral part, a substance orhuman blood derivative referred to in Section 7.4 of Annex I,

— a statement indicating whether or not the device is manufactured utilising tissues of animal origin asreferred to in Directive 2003/32/EC,’;

(d) in Section 3.1, the first paragraph shall be replaced by the following:

‘3.1. For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understandingof the design, manufacture and performances of the product, including the expected performances, so asto allow assessment of conformity with the requirements of this Directive.’;

(e) Section 3.2 shall be replaced by the following:

‘3.2. For devices intended for clinical investigations, the documentation must contain:

— a general description of the product and its intended use,

— design drawings, methods of manufacture envisaged, in particular as regards sterilisation, anddiagrams of components, sub-assemblies, circuits, etc.,

— the descriptions and explanations necessary to understand the abovementioned drawings anddiagrams and the operation of the product,


— the results of the risk analysis and a list of the standards referred to in Article 5, applied in full or inpart, and descriptions of the solutions adopted to meet the essential requirements of this Directive ifthe standards referred to in Article 5 have not been applied,

— if the device incorporates, as an integral part, a substance or human blood derivative referred to inSection 7.4 of Annex I, the data on the tests conducted in this connection which are required toassess the safety, quality and usefulness of that substance or human blood derivative, taking accountof the intended purpose of the device,

— if the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC, the risk management measures in this connection which have been applied to reduce the risk ofinfection,

— the results of the design calculations, and of the inspections and technical tests carried out, etc.

The manufacturer must take all the measures necessary to ensure that the manufacturing process producesproducts which are manufactured in accordance with the documentation referred to in the first paragraph ofthis Section.

The manufacturer must authorise the assessment, or audit where necessary, of the effectiveness of thesemeasures.’;

(f) Section 4 shall be replaced by the following:

‘4. The information contained in the declarations concerned by this Annex shall be kept for a period of timeof at least five years. In the case of implantable devices the period shall be at least 15 years.’;

(g) the following section shall be added:

‘5. For custom-made devices, the manufacturer must undertake to review and document experience gained inthe post-production phase, including the provisions referred to in Annex X, and to implement appropriatemeans to apply any necessary corrective action. This undertaking must include an obligation for themanufacturer to notify the competent authorities of the following incidents immediately on learning ofthem and the relevant corrective actions:

(i) any malfunction or deterioration in the characteristics and/or performance of a device, as well asany inadequacy in the labelling or the instructions for use which might lead to or might have led tothe death of a patient or user or to a serious deterioration in his state of health;

(ii) any technical or medical reason connected with the characteristics or performance of a device forthe reasons referred to in subparagraph (i) leading to systematic recall of devices of the same type bythe manufacturer.’;

9. Annex IX shall be amended as follows:

(a) Chapter I shall be amended as follows:

(i) in Section 1.4, the following sentence shall be added:

‘Stand alone software is considered to be an active medical device.’;

(ii) Section 1.7 shall be replaced by the following:

‘1.7. Central circulatory system

For the purposes of this Directive, “central circulatory system” means the following vessels:

arteriae pulmonales, aorta ascendens, arcus aorta, aorta descendens to the bifurcatio aortae, arteriaecoronariae, arteria carotis communis, arteria carotis externa, arteria carotis interna, arteriaecerebrales, truncus brachiocephalicus, venae cordis, venae pulmonales, vena cava superior, venacava inferior.’;


(b) in Chapter II, Section 2, the following section shall be added:

‘2.6. In calculating the duration referred to in Section 1.1 of Chapter I, continuous use means “an uninterruptedactual use of the device for the intended purpose”. However where usage of a device is discontinued inorder for the device to be replaced immediately by the same or an identical device this shall be consideredan extension of the continuous use of the device.’;

(c) Chapter III shall be amended as follows:

(i) the introductory phrase of the first paragraph of Section 2.1 shall be replaced by the following:

‘All invasive devices with respect to body orifices, other than surgically invasive devices and which are notintended for connection to an active medical device or which are intended for connection to an activemedical device in Class I:’;

(ii) Section 2.2 shall be replaced by the following:

‘2.2. Rule 6

All surgically invasive devices intended for transient use are in Class IIa unless they are:

— intended specifically to control, diagnose, monitor or correct a defect of the heart or of thecentral circulatory system through direct contact with these parts of the body, in which casethey are in Class III,

— reusable surgical instruments, in which case they are in Class I,

— intended specifically for use in direct contact with the central nervous system, in which casethey are in Class III,

— intended to supply energy in the form of ionising radiation in which case they are in Class IIb,

— intended to have a biological effect or to be wholly or mainly absorbed in which case they arein Class IIb,

— intended to administer medicines by means of a delivery system, if this is done in a mannerthat is potentially hazardous taking account of the mode of application, in which case they arein Class IIb.’;

(iii) in Section 2.3, the first indent shall be replaced by the following:

‘— either specifically to control, diagnose, monitor or correct a defect of the heart or of the centralcirculatory system through direct contact with these parts of the body, in which case they are inClass III,’;

(iv) in Section 4.1, first paragraph, the reference ‘65/65/EEC’ shall be replaced by the reference ‘2001/83/EC’;

(v) in Section 4.1, the second paragraph shall be replaced by the following:

‘All devices incorporating, as an integral part, a human blood derivative are in Class III.’;

(vi) in Section 4.3, second paragraph, the following phrase shall be added:

‘unless they are specifically to be used for disinfecting invasive devices in which case they are in Class IIb.’;

(vii) in Section 4.4, the words ‘Non-active devices’ shall be replaced by the word ‘Devices’;


10. Annex X shall be amended as follows:

(a) Section 1.1 shall be replaced by the following:

‘1.1. As a general rule, confirmation of conformity with the requirements concerning the characteristics andperformances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of thedevice, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred toin Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referredto as “clinical evaluation”, where appropriate taking account of any relevant harmonised standards, mustfollow a defined and methodologically sound procedure based on:

1.1.1. Either a critical evaluation of the relevant scientific literature currently available relating to the safety,performance, design characteristics and intended purpose of the device, where:

— there is demonstration of equivalence of the device to the device to which the data relates, and

— the data adequately demonstrate compliance with the relevant essential requirements.

1.1.2. Or a critical evaluation of the results of all clinical investigations made.

1.1.3. Or a critical evaluation of the combined clinical data provided in 1.1.1 and 1.1.2.’

(b) The following Sections shall be inserted:

‘1.1a In the case of implantable devices and devices in Class III clinical investigations shall be performedunless it is duly justified to rely on existing clinical data.

1.1b The clinical evaluation and its outcome shall be documented. This documentation shall be includedand/or fully referenced in the technical documentation of the device.

1.1c The clinical evaluation and its documentation must be actively updated with data obtained from thepost-market surveillance. Where post-market clinical follow-up as part of the post-market surveillanceplan for the device is not deemed necessary, this must be duly justified and documented.

1.1d Where demonstration of conformity with essential requirements based on clinical data is not deemedappropriate, adequate justification for any such exclusion has to be given based on risk managementoutput and under consideration of the specifics of the device/body interaction, the clinicalperformances intended and the claims of the manufacturer. Adequacy of demonstration of conformitywith the essential requirements by performance evaluation, bench testing and pre-clinical evaluationalone has to be duly substantiated.’;

(c) in Section 2.2, the first sentence shall be replaced by the following:

‘Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18thWorld Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly.’;

(d) Section 2.3.5 shall be replaced by the following:

‘2.3.5. All serious adverse events must be fully recorded and immediately notified to all competent authoritiesof the Member States in which the clinical investigation is being performed.’.


Documents

EU Medical Device Directive - MDD 93/42/EC - ROCH...devices are liable to act upon the body with action ancillary to that of the device, the placing of the devices on the market is