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Slide 1
Understanding the Transition Provisions, Re-Certification and Reclassification Components of MDR
December 5th, 2017
Ibim Tariah Ph.D
BSI Group Americas Inc.
Slide 2
1. Roles in the regulatory system:– European Union: Commission, Parliament, Council.– Member States– Notified Bodies– Economic Operators: Manufacturers, EU Reps, Importers & Distributors
2. Summary of MDR CE Marking Process:– Process Overview– Classification Rules / Conformity Assessments– GSPR’s– Harmonized Standards & Common Specifications
3. Notified Body Designation & Transition Provisions:– Designation process– Transition provisions– Conclusions
This Presentation:
Slide 3
History
Slide 4
The EU’s Medical Device Regulations History
2008
2012
2014 Q2
2015 Q3
2015 Q4
May 2017
EU Commission launches consultation on MD framework
EU Commission publishes proposal for new MD Regulations
EU Parliament adopts position on MDR
EU Council adopts position on proposed Regulations
Trilogues between Commission, Parliament and Council starts
Publication of Drafts: MDR and IVDR 2016 Q2/2017 Q1
Publication of MDR and IVDR in EUOJ
Slide 5
Regulation (EU) 2017/745
Slide 6
Roles in the Regulatory System
Slide 7
European Commission, Parliament, Council
Member States EU, EEA, EFTA, Customs
Union, MRANotified Bodies
ManufacturerSuppliers
SubcontractorsEU Authorised Representative
ImporterDistributor
New Legislative Framework
2016 Actors – What do they do? Blue Guide
Slide 8
AdministrationDevelopment comprehensive,
coherent and proportionate legislation
Support Member States, Ensure co-operation between NBs,
Harmonised Standards, NANDO
National Law EnforcementEnsure only safe, compliant
products on marketDesignate Notified Bodies
Conformity AssessmentQMS, Product, Unannounced
Manufacturer, Suppliers, Subcontractor
‘… ultimate responsibility for conformity …’
Market Surveillance
New Legislative Framework
2016 Actors – What do they do? Blue Guide
Slide 9
How to Read 177 pages of (EU) 2017/745…..
Slide 1006/12/20
101 Whereas…
Why
X Chapters of 123 Articles
What
XVI Annexes
How
I. Scope and DefinitionsII. Making available on the market and putting
into service, obligations of economic operators, reprocessing, CE marking, free movement
III. Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
IV. Notified BodiesV. Classification and conformity assessmentVI. Clinical evaluation and clinical investigationsVII. Post-market surveillance, vigilance and market
surveillanceVIII. Cooperation between Member states, Medical
Device Coordination Group, expert laboratories, expert panels and device registers
IX. Confidentiality, data protection, funding and penalties
X. Final Provisions
Slide 1106/12/20
XVII AnnexesI. General Safety and Performance RequirementsII. Technical DocumentationIII. Technical Documentation on Post-Market SurveillanceIV. EU Declaration of ConformityV. CE Marking of ConformityVI. Information to be submitted with registration of devices
and economic operators and core data elements to be provided to the UDI data-base
VII. Requirements to be met by Notified BodiesVIII. Classification RulesIX. Conformity Assessment – QMS & Technical
DocumentationX. Conformity Assessment – Type ExaminationXI. Conformity Assessment – Product Conformity
VerificationXII. Certificates issued by a Notified BodyXIII. Procedure for Custom-made DevicesXIV. Clinical Evaluation and Post-market clinical follow-upXV. Clinical InvestigationsXVI. List of groups of products without an intended medical
purposeXVII.Correlation Table
101 Whereas…
Why
X Chapters of 123 Articles
What
XVII Annexes
How
Slide 12
Implementing and Delegated Acts
• Many instances of delegated acts and implementing actsnecessary to makeMDR “operational”
• Unclear when thesewill be available…
e.g:• Regulatory status of groups of
products• Common Specifications• Format of Summary of Safety and
Performance• UDI• EUDAMED• List of NBOG codes• NB designation procedure
…
Slide 13
Copyright © 2016 BSI. All rights reserved.
MDR Key Changes:
Slide 14
• Strengthened Designation Criteria• Joint Audits: Three Member States and
Commission (FHAA)• Unannounced audits
Notified Bodies
• Less Equivalence, More Data for High Risk Devices
• Publish Safety and Performance Data• Post Market Clinical Follow-up
Clinical Evidence
• Scrutiny for High Risk Devices• Common Specifications• Responsible Person for Manufacturers and
Authorised RepresentativesPre-market
Slide 15
• Central Database and Co-ordination• Trend Reporting• Enforcement Activities
Post-Market Surveillance and
Vigilance
• Devices and Economic Operators Registered Centrally
• Unique Device Identification (UDI)• Implant Cards
Transparency and Traceability
• Central Committee: MDCG• Expert Panel, Expert Laboratories
Governance and Oversight
Slide 16
Electronic System on
Registration/ Conformity Assessment
Applications + Summary of Safety and
Clinical Performance
Electronic System on UDI
Electronic System on Certificates
(issued, reissued, refused,
suspended, withdrawn)
Electronic System on Vigilance
(incidents, FSCA, FSN)
+ Periodic Safety Update
Report
Electronic System on
Market Surveillance(measures taken
by Member States)
Electronic System on
Clinical Investigations
(sponsors, description of investigational
device, comparators,
purpose, status)
EUDAMED
Electronic System on Registration –Manufacturers & Authorised Representatives – SRN
Slide 17
MDR ClassificationAnnex VIII
Slide 18
Classification Rules – MDR, Annex VIII
MDR MDDRules 1 – 4: Non-invasive devices
Rules 5 – 8 : Invasive devices
Rules 9 – 13 : Active Devices
Rules 14 – 22 : Special rules
Rules 1 – 4 : Non-invasive devices
Rules 5 – 8 : Invasive devices
Rules 9 – 12 : Active devices
Rules 13 – 18 : Special rules
Slide 19
Summary of MDR CE Marking Process
Copyright © 2016 BSI. All rights reserved.
Slide 20
1. Check Device is within Scope of MDR (Chapter I, Articles 1, 2, Annex XVI)
2. Determine “Device Class” (Chapter V, Article 51, Annex VIII)
3. Select “Conformity Assessment Procedure” (Chapter V, Article 52)
4. Identify Applicable “Safety and Performance Requirements” (Chapter II, Article 5, Annex I)
5. Assign UDI (Chapter III, Article 27, Annex VI)
6. Assemble “Technical Documentation” (Annex I => Annex II, Annex XV)
7. Apply Conformity Assessment Procedure (Annexes IX, X, XIA or XIB)
8. Complete “Declaration of Conformity” (Chapter II, Article 19, Annex IV)
9. Affix “CE Mark” (Chapter II, Article 20, Annex V)
10. Post Market Surveillance & Updates Technical Documentation (Chapter VII, Articles 83 to 86, Annex XIV => Annex III)
MDR CE marking on a single slide
Slide 21
Competent Authority Assessment
Notified Body Conformity Assessment
Self-Certification
Class III
Class IIb
RiskClass IIa
Class Im /Is
Class ICustom Made
Classification & Conformity Assessment – MDD
Slide 22
Commission Assessment
Competent Authority Assessment
Notified Body Conformity Assessment
Self-Certification
Class III Custom Made Implants
Class Ir
Class III ImplantsClass IIb active – administer
medicine
Class III
Class IIb
RiskClass IIa
Class Im /Is
Class ICustom Made
Class IIb Implants
Classification & Conformity Assessment – MDR
Slide 23
Annex I – GSPR’s• The General Safety And Performance Requirements serve an
analogous function to the Annex I Essential Requirements in the MDD
• The are 3 major chapters– I. General requirements (1 to 9)– II. Requirements regarding design and manufacture (10 to 22)– III. Requirements regarding the information supplied with the
device (23)
• Chapter II has a large number of subsections
23
Slide 24
• Devices in conformity with the relevant harmonized standards, or the relevant parts of those standards (published in the Official Journal) are presumed to in conformity with those requirements of this Regulation [Article 8]
• In some cases (such as no or insufficient harmonized standard) the Commission may adopt common specifications (CS) [Article 9]
– Common specification (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
24
Harmonized Standards and Common Specifications
Slide 25
2007 – 2024 EU Regulations
25
Time
Req
uire
men
ts
Interim Regulations & Recommendations
Future Regulation
2017
UnannouncedAudits
Joint Assessments
Clinical Oversight
Slide 26
NB’s Designation under the MDR
Copyright © 2016 BSI. All rights reserved.
Slide 2727
26 November 2017
✔
EU MDR / IVDR – Designation – Article 38-40 / 38-40
Slide 28
Transition Provisions (Article 120 of MDR)
Copyright © 2016 BSI. All rights reserved.
Slide 29
MDR Transition (Article 120)
05 May 2017Adoption of MDR
Entry into Force (OJEC + 20days)(25 May 2017)
NBs designation under MDR
Date of Application(26 May 2020)
Last MDD/AIMD certificates expire
(27 May 2024)
MDD/AIMD certificate validity(4 years )
MDD/AIMD certificates (max 5-year expiry from issue/renewal date)
MDR certificates
Transition period 3 years
Annex IV certificates expire (27 May 2022)
27 May 2025No more « placing on the
market » of devices covered by MDD/AIMD certificates
NB’s Designation Application (26 Nov 2017)
Slide 30
MDR Transition (Article 120)
Adoption of MDR05 May 2017
Entry in to Force 25 May 2017
NBs designationunder MDR
MDD/AIMDD certificate validity(4 years )
MDD/AIMDD certificates can be issued/re-issued/renewed
MDR certificates
Transition period3 years
MDD/AIMDD Annex IV certificatesvoid on 27 May 2022
No more « making availableor putting into service » of
devices covered by MDD/AIMDD certificates
MDD/AIMDD certificates void27 May 2024
27 May 2025
NBs can apply for designation26 Nov 2017
• No significant chang purpose
• Post market surveilla• Market surveillance• Vigilance• Registration of econo
Date of Application26 May 2020
• Class I reusable• Class III custom made implantable• Devices with no Medical Purpose (Once Common
Specifications are available)
Slide 31
MDR Transition (Article 120)
However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.
Slide 32
The Clock is Ticking!• What products currently on the EU market?
• What products on the market post 2024?
• What needs certification in 2022 / 2024?
• What is ‘in’ the MDR that wasn’t previously? i.e. Will need CE Certification sooner?
• What is reclassified?
• What are your priority products?
Slide 33
• Become familiar with MDR. • Conduct MDR impact assessment on your business.• Create Work Groups for key sections.• Plan how to:
Maintain MDD in your organization till end of grace period. Implement MDR in your organization. Handle Significant changes & Intended Use changes from Date of Application Implementation of PMS, Vigilance, Registration, Incident Reporting and
Responsible Person from Date of Application.• Hire competent people.
06/12/20
Conclusions:
Slide 34
34
Thank You….