Practical Implications for Manufacturers

THE NEW EU MEDICAL DEVICE REGULATION (MDR):Practical Implications for Manufacturers

Updated July 2020

175 PAGESeffective May 26, 2021

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INTRODUCTION This whitepaper is updated to reflect the one year extension to the Date of Application (DoA) for the European Union’s Medical Device Regulation (EU MDR), due to the COVID-19 pandemic.

The new DoA of May 26, 2021 was approved by the European Parliament in an amendment to the original regulation. The vote to delay was approved by an overwhelming margin on April 17, 2020 and the amendment was published in the Official Journal of the European Union on April 23, 2020.

The amendment also made updates to two articles: Article 59, Derogations from the conformity assessment procedures; and Article 120, Transitional provisions. These updates are covered in further detail later in this whitepaper.

In addition to the April 2020 amendment, there have also been 2 corrigenda published in the Official Journal that mainly correct minor mistakes and inconsistencies, and make a few clarifications to the meaning of statements. The first was dated May 3, 2019 and had 14 amendments; the second was dated November 25, 2019 and had 12 amendments. Most of the amendments in these corrigenda make simple fixes, such as changing

1 Procedure2012/0266/COD.COM(2012)542:ProposalforaRegulationoftheEuropeanParliamentandoftheCouncilonmedicaldevices,andamendingDirective2001/83/EC,Regulation(EC)No178/2002andRegulation(EC)No1223/2009,eur-lex.europa.eu›EUROPA›EUlawandpublications›EUR-Lex

the word “trademark” to “trade mark.” One of the updates in the second corrigenda clarified the transition timeline for reusable and sterile Class I devices (Class Ir and Class Is.)

The delay to the DoA was welcomed by the industry, as businesses faced new and extraordinary challenges due to the global health crisis. The regulatory requirements remain the same for Medical Device Manufacturers, Notified Bodies, Authorized Representatives, Importers and Distributors. However, businesses are using the additional time to continue efforts to be fully ready for EU MDR compliance.

The EU MDR is a ‘fundamental revision... of the earlier Directives [and] is intended to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation’1.

It is important to note that the Regulation has binding legal force throughout the EU and enters into force simultaneously in all the Member States. (By contrast, Directives lay down a set of specific results that must be achieved; each Member State is free to decide how to transpose these directives into national laws.)

The new Regulation is a complex and lengthy document and the changes it embodies are significant. This white paper analyses the most influential changes and highlights their implications for regulated companies. Most of all, it aims to provide practical steps that manufacturers should take as soon as possible to prepare for this substantial and unprecedented change in the European regulatory environment for medical devices. NOTE: Another new EU Regulation, the In Vitro Diagnostic Regulation (EU IVDR), was also published in parallel with the EU MDR. While this merits the full attention of regulated manufacturers of IVDs and also involves significant changes, this regulation is beyond the scope of the current white paper and is not considered further here. Maetrics has published a separate white paper (available from www.maetrics.com) on EU IVDR compliance. It is also worth noting the DoA extension for the EU MDR does not impact the EU IVDR.

The EU MDR is officially known as REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 5, 2017 on medical devices. It is amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. It will consolidate two existing legal provisions and replace both the current Medical Device Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC).


SIGNIFICANT CHANGES IN THE MEDICAL DEVICE REGULATION AND THEIR IMPLICATION FOR MANUFACTURERSThe industry recognizes that the EU MDR represents a significant change in the regulatory environment:2

IN A SURVEY OF INDUSTRY PROFESSIONALS2:

+ Most respondents were aware of coming changes to the European CE marking process as well as to the ISO 13485 quality system standard, but primarily on a high level.

+ The majority of participants cited changing regulatory environments as their biggest challenge.

+ A high proportion of firms based in Europe said they were already closely tracking proposed changes related to CE Marking, compared to much smaller percentages of North American and Asian respondents.

It is important that all affected manufacturers carefully consider and thoroughly understand the full impact of the EU MDR in order to implement their strategy for complying with this important regulatory event.

Many businesses have implemented transition plans, and often the plans include prioritisation criteria to address product readiness for new or updated submissions, including technical documentation remediation. A typical product submission takes between 6 and 9 months, and resource constraints may have resulted in the need to prioritize efforts. The DoA extension allows additional time to be ready for compliance to EU MDR requirements.

2. Emergo,GlobalMedicalDeviceIndustryOutlookfor2017

Areas of significant change include: reclassification, market access of legacy products, reprocessing of single use devices, technical documentation, clinical evaluation, vigilance and post market surveillance, product liability insurance, transparency, the supply chain, labelling and UDI.

Reclassification CHANGE

Certain products have received special consideration in the EU MDR and are subject to reclassification (EU MDR Article 4). These new provisions variously apply to cosmetic implants, standalone software, products without an intended medical purpose (EU MDR Annex XVI), certain spine products and reusable Class I devices.

IMPLICATION FOR MANUFACTURER

Manufacturers of medical devices should carefully examine the EU MDR Classification rules in Annex VIII to determine whether new conformity assessment routes are now applicable to their product portfolio. If so, they should engage their Notified Body (where necessary) and take steps to evaluate the necessary timescales involved in implementing this change. In some cases, where reclassification has occurred, this may be the first time that such relationships and agreements with Notified Bodies have been required.

Market Access of Legacy Products CHANGE

There is no provision for allowing existing device certifications (CE Marks) obtained under the previous directives. All products have to be CE marked under the new Regulation 2017/745, in order to be placed on the market or put into service (EU MDR Article 5) after the transition period.



A comprehensive plan needs to be put in place to ensure that all products that will be maintained on the EU market are CE marked in accordance with the full requirements of the new EU MDR. This should include products currently under development. This review may provide an opportunity for rationalisation of the product portfolio and elimination of any marginal products.

Reprocessing of Single Use Devices CHANGE

This has been a highly controversial topic during the evolution of the EU MDR. It is now specified in the EU MDR that the reprocessing and further use of single-use devices should only take place where permitted by national law, while complying with requirements laid down in the Regulation (EU MDR Article 17). Reprocessors are considered equivalent to manufacturers and therefore must ensure an equivalent level of safety and performance to that of the corresponding initial single-use device.


Reprocessing must only take place if permitted by the relevant national law and reprocessors have the same obligations as device manufacturers. Reprocessors should check that reprocessing will be permitted in their national law and if so, understand and embrace the full implications, requirements and obligations of a device manufacturer. Prior to the EU MDR, they may not have had to consider these aspects and up-skilling or additional staff may be required should relevant professionals not already exist in the company.

3 SummaryTechnicalDocumentation(STED)forDemonstratingConformitytotheEssentialPrinciplesofSafetyandPerformanceofMedicalDevicesGHTF/SG1/N011:2008

Technical Documentation CHANGE

The EU MDR is significantly more prescriptive about the required content of Technical Documentation (previously known as Technical Files or Design Dossiers):

+ Essential Requirements (ERs) are replaced by “General Safety Requirements (EU MDR Annex I) and the number of requirements has been expanded.

+ A presumption of conformity still applies for devices that are in conformity with relevant harmonised standards (EU MDR Article 8), but the Commission may define Common Specifications where no harmonised standards exist or where they are considered insufficient.

Additionally, there are more detailed requirements for the Quality Management Systems (QMS) (EU MDR Annex IX). EN ISO 13485:2016 was re-written and issued in 2016 with the new EU MDR very much in mind. It should be noted that while EN ISO 13485:2016 is not an absolute requirement there will be a general expectation that this standard will be used.


The required Technical Documentation is heavily based on the current GHTF STED Guidance document3 reflecting the harmonisation intent of global regulators. Accordingly, the continuing sufficiency of the Technical Documentation including associated checklists will need to be checked in detail. Manufacturers will need to remain alert to the publication of new Common Specifications. In addition, manufacturers should be aware of a new sub section related to required Post Market Surveillance (PMS) information.


Clinical Evaluation

CHANGE

The EU MDR is more specific about the need for clinical evidence and clinical evaluation, proportionate with the risk associated with a given device (EU MDR Annex XIV, Part A).

Reliance on the scientific literature to demonstrate equivalence will be more tightly regulated, and clinical evaluations will be more closely aligned with clinical trials associated with medicinal products.


This may require manufacturers to obtain additional clinical data from clinical studies. There will be additional scrutiny of Clinical Evaluation Reports (CERs) by Notified Bodies as outlined by new guidance (MEDDEV 2.7.1 rev. 4)4. CERs that previously were of a suitable level and standard and accepted by Notified Bodies, may no longer be accepted. Manufacturers should plan to review all of their CERs if not reviewed within the last 1-2 years and ensure that CERs include Post Market Surveillance data, especially where devices are new to market and where clinical data was limited at the time of first CE Marking.

Vigilance and Post Market Surveillance (PMS)

CHANGE

Under the new Regulation 2017/745, device manufacturers will be required to collect post-market clinical data as part of their ongoing assessment of potential safety risks. Post Market Clinical Follow up (PMCF) is a continuous process with the objective of constantly updating the clinical evaluation (EU MDR Annex XIV, Part B).

4 MEDDEV2.7.1revision4,June2016.GuidelinesonMedicalDevices.ClinicalEvaluation:AGuideforManufacturersandNotifiedBodiesUnderDirectives93/42/EECand90/385/EEC

Additionally, reporting timeframes are tightened from 30 days to 15 days for reporting serious incidents (EU MDR Article 87).

There will be new electronic vigilance reporting (EU MDR Article 92) and Periodic Safety Update Reports (PSUR) for all devices (EU MDR Article 86), subject to differing frequency and submission requirements.


Manufacturers need to review their procedures for PMS and ensure that the responsibility for the provision of this additional data and associated support is clearly established. This is likely to require additional resources in functions that support products on the market such as Regulatory and Medical Affairs.

Mandatory Product Liability Insurance

CHANGE

Manufacturers must be able to provide sufficient financial coverage for their potential liability. This provision will be based on risk class, type of device and the size of the enterprise (EU MDR Article 10.16).


Manufacturers need to review their Product Liability provisions under advice from legal counsel.

Transparency

CHANGE

Transparency is one of the guiding principles expounded in the EU MDR preamble: “transparency and adequate access to information, appropriately presented for the intended user, are essential in


the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system’’.

This will take the form of a European Database on Medical Devices (EUDAMED) (EU MDR Article 33) which will also be made public for certain devices. On their part, manufacturers will need to register all products in the EUDAMED database.


Manufacturers should closely follow the continuing evolution of the EUDAMED system and prepare for its implementation so as to be able to notify all products to the EUDAMED database. The full implementation of EUDAMED has been delayed and the new implementation date has been chosen to coincide with the DoA for the EU IVDR: May 26, 2022. Modules will be made available as they are functional5.

The first module, for actor registration, is expected to be available by March 2021. The second module, for UDI/Device registration, is expected to be available by May 2021.

Supply Chain

CHANGE

Each manufacturer will be required to appoint a Person Responsible for Regulatory Compliance (PRRC). In early drafts of the EU MDR this was first referred to as a “Qualified Person”; however this was deemed to be confusing with the pharmaceutical industry’s QP and the role is now referred to as PRRC (EU MDR Article 15). The PRRC must have: a university degree or equivalent in a relevant scientific discipline, and at least one year of professional experience; or four years of professional experience.

There are also more prescriptive requirements placed on EU Authorised Representatives (EUAR)

5 EuropeanCommission,MedicalDevices–Eudamed:Overview,https://ec.europa.eu/health/md_eudamed/overview_en

(EU MDR Article 11). The EU MDR states that “the authorised representative should be jointly and severally liable with the importer and the manufacturer“. The EUAR will be required to be registered and must also have a PRRC.

The EU MDR extends the scope of the regulation beyond the device manufacturer to other Economic Operators in the supply chain. Distributors and Importers are now specifically regulated (EU MDR Article 25) and therefore have specific regulatory obligations.


Manufacturers should consider their entire supply chain to ensure that these provisions are adequately addressed and agreed with their business partners. In addition, they should identify a person who is suitably qualified to assume the PRRC role. Agreements with EUARs, if used, should be revisited and updated together ensuring that EUARs have defined plans to be registered and have appropriate levels of insurance to cover their new liability; both parties must also have mutual letters of authority for each other.

Labelling

CHANGE

Requirements for product labelling are more prescriptive under EU MDR than before. For example, information supplied by the manufacturer must be made available and kept up to date on the manufacturer’s website (EU MDR Chapter III, 23.1).

There are requirements for:

+ Specific details for labels and for sterile packages (EU MDR Annex I).

+ Inclusion of information on residual risks for vulnerable patient groups (e.g. children, pregnant or nursing women) and, if applicable, on appropriate precautionary measures in the instructions for use.

+ Hazardous substances.



Manufacturers should carefully review the adequacy of their product labelling and precautionary statements and consider how this will be reflected on their websites.

UDI System

CHANGE

To significantly improve the effectiveness of post-market safety related activities, the EU MDR requires the traceability of all devices placed on the EU market (except custom made devices) by means of a Unique Device Identification system (UDI System) based on international guidance (EU MDR Articles 27, 29 and 31 & EU MDR Annex VI).

Each device will need to have an assigned UDI obtained from a UDI supplier and this information must be uploaded into EUDAMED. The UDI must be established before the product is placed on the market, and the UDI carrier must be provided on the device label/packaging, and, in the case of reusable devices, on the device itself.

In the same amendment published in April 2020 that extended the DoA, another change was made regarding the implementation date for the product-based UDI requirements. There are now staggered implementation dates for reusable devices which bear the UDI carrier on the device itself.

The new implementation dates are as follows:

2027

2025

2023

Class III & Implantable

Class IIa and Class IIb

Class I

+ May 26, 2023 for implantable devices and Class III devices;

+ May 26, 2025 for Class IIa and Class IIb devices;

+ May 26, 2027 for Class I devices.


Detailed project planning for UDI Implementation in the EU will be required (additional to what is currently required by the FDA in the US). While the detailed specification of the EU UDI system is still unpublished, there are several guidance documents from the Medical Device Coordination Group (MDCG) available and current information suggests it will not differ significantly from the US system. Manufacturers who do not supply their products to the US will have the steepest learning curve on EU UDI, however they can also learn from the successes and mistakes of US UDI implementation.

SOME IMPORTANT PRACTICALITIES OF IMPLEMENTATION

Timeline Following its formal adoption, the EU MDR was published in the Official Journal of the European Union on May 5, 2017 and was followed up with 2 corrigenda and 1 formal amendment. The regulation established a transition period following its publication and established a date when it would enter fully into force. That date is known as the Date of Application, and as indicated previously, has changed from May 26, 2020 to May 26, 2021. After this date it will no longer be possible to put a new medical device on the market with a CE mark issued against the former Directives.

New Projected Timeline of Implementation of EU MDR Devices placed on the market under the Directives 90/385/EEC and 93/42/EEC before the EU MDR Date of Application (May 2021) may continue to be made available on the market or put into service until May 26, 2024, provided they have not expired (EU MDR Article 94.3a), and as long as there is not a significant change, as determined by the notified body and competent authorities.


The amendment published in April 2020 also included an update to Article 120, Transitional provisions. Previously it was understood that all Class I devices would be required to comply as of the date of application. However, the amendment clarified requirements for Class I devices with a declaration of conformity prior to May 26, 2021, and for which assessment under the EU MDR requirements would require a notified body. The transition date of May 2024 now includes these Class I devices, aligned with guidance previously published by the MDCG.

The transition timeline for devices are now as follows:

+ All Class I non-reusable, non-sterile and non-measuring devices by May 26, 2021

+ All new to market devices (irrespective of class) from May 26, 2021

+ All devices up-classified from Class I (Class I r/s/m, Class IIa or higher) from May 26, 2024

+ All Class II and III devices with valid CE certificates prior to May 26, 2020, by the expiration date of their certificate, or May 26, 2024, whichever comes first.

UK Brexit The decision of the UK to exit the EU (Brexit) following a referendum held in June 2016 and formalised by the triggering of Article 50 in March 2017 complicates the situation for UK based manufacturers, non-EU companies with Authorised Representatives in the UK, and companies wanting to continue to access the UK market. However, it remains unlikely that the UK government will devise a new national regulatory regimen that differs significantly in its requirements from that of the EU MDR. Thus any future UK regulatory regimen is likely to closely mirror that of the EU.

To this end, The UK Association for British Health Industries (ABHI) has published a white paper on its website advocating a pragmatic UK approach to compliance with the current and future EU regulation for medical devices, and for the UK to remain part of the CE marking regime. Nonetheless, the possibility that additional bureaucratic overheads may be encountered in the UK going forward certainly exists. Manufacturers should closely monitor further developments in the UK so as to anticipate any significant consequences for their business.


Notified Body Capacity After some well publicised safety issues in recent years that have strongly influenced the evolution of the EU MDR, Notified Bodies (NBs) are under considerable pressure from their respective Competent Authorities to heighten scrutiny of their client medical device manufacturers.

Notified Bodies themselves must seek designation under the EU MDR. In the EU there are fewer Notified Bodies designated than under the MDD, though the DoA extension allows more time for additional Notified Bodies to be designated. There has been a significant decrease in the number of Notified Bodies accredited to deal with medical devices in spite of a substantial increase in workload; Notified Bodies across Europe have encountered capacity issues as a result. With the EU MDR coming into play, Notified Bodies will also need time to prepare and train their staff.

The lack of Notified Body capacity suggests there will be significant over-demand from the industry for Notified Body services as manufacturers compete for their services during the transitional period, even though it is now extended. It is vital that manufacturers engage with their Notified Body early and ensure they have the capacity to assist them, and that they agree on timescales.

It is also worth noting that Notified Bodies are restricted from providing consultancy. This has always been true, but the enforcement of it has become stricter in recent times. As a result, at least one Notified Body has taken the strategic decision to limit the number of rounds of questions following a product submission under EU MDR to just three. This also allows the notified bodies to more effectively manage resources. If issues cannot be resolved during the rounds of questions, then the submission may be rejected, and the manufacturer would have to reapply.

UNANNOUNCED INSPECTIONS Notified Bodies have been conducting unannounced inspection of manufacturers, their critical subcontractors, and their suppliers for some time now. Under the EU MDR such inspections

must be performed at least once every five years. Manufacturers should put in place formal procedures to deal with these, if they have not already done so, and should always be prepared for an audit.

Delegated Acts There will be ongoing changes that must be monitored to plan for and confirm compliance. One source of future change is related to 12 areas in the regulation, considered Delegated Acts under the authority of Article 115, where changes can be made without going back through the European Parliament. These are used to supplement the existing legislation on non-essential parts or amend specific and non-essential elements of the regulation.

It is important that manufacturers closely follow any developments and have the option to actively engage with their industry associations on these issues.

Changes can be made in any of the following 12 areas:

Article 1(5): Amend list of products without a medical purpose, Annex XVI products

Article 3: Amend definition of nano materials

Article 10(4): Amend requirements for Technical Documentation (Annex II) and Technical Documentation for PMS (Annex III)

Article 18(3): Amend exemptions from Implant Cards

Article 19(4): Amend minimum content of Declaration of Conformity

Article 27(10): Amend info required from Economic Operators

Article 44(11): Amend frequency that NBs should be re-evaluated

Article 52(5): Amendments to conformity assessments of certain Class IIb implants (e.g. staples, sutures). Adding to and/or removing from the list


Article 56(6); Amending the minimum elements of a Certificate of Conformity

Article 61(8): Clinical Evaluation requirements for certain class III devices. Adding to and/or removing from the list

Article 70(8): Amending requirements for the application of a Clinical Investigation

Article 106(15): Amending the tasks of expert panels providing advice

Implementing Acts In addition to the Delegated Acts described above there are a number of Implementing Acts that are required before the EU MDR can become fully functional. These Implementing Acts feature in the EU MDR and EU IVDR implementing measures rolling plan, which may be found at https://ec.europa.eu/docsroom/documents/41501.

Examples of Implementing Acts completed include:

+ Definition of the list of codes and corresponding types of devices, for the purpose of specifying the scope of the designation of notified bodies.

+ Provision for expert panels to be designated.

+ Designation of one or more entities to operate a system for assignment of UDIs.

+ The DoA extension allows additional time for the remaining Implementing Acts to be established. It is important that manufacturers closely follow these developments and have the option of actively engaging with their industry associations on these topics.

ISO 13485 Quality System In addition to needing to comply with Regulation 2017/745 requirements, the medical device industry should by now have completely transitioned to the revised ISO 13485:2016 standard required for medical device QMS which is itself a de facto requirement for medical devices placed on the EU market. The transition period for complying to the update to this standard ended March 1st, 2019, overlapping closely with the EU MDR transition period.

STEPS MANUFACTURERS SHOULD TAKE NOW It is evident that conformance with the EU MDR is a significant business issue; all products on the market must be phased into the new system no later than the end of the transition period. All new products being placed on the market after the DoA must be compliant with the EU MDR. Furthermore, regulatory control over conformance with the requirements of the EU MDR is ever-increasing.

Additional Costs and Resource Requirements EU MDR conformance will place a considerable additional administrative burden on manufacturers. Both staffing and external cost budgets should be carefully considered and adjusted to ensure that timely access to the EU market is not compromised and that regulatory compliance is maintained in the face of significantly enhanced scrutiny.

Many manufacturers will continue to rely on additional resources to assist with the workload at a time when there is a shortage of skilled professionals. Manufacturers who plan and implement sooner rather than later will have the best access to limited resources. When budgeting, manufacturers must allow for this fluctuation and also be aware that it is a candidate’s market so they will need to act fast to secure top professionals. Considering a managed outsourcing partner can ease the internal resourcing burden whilst maximising knowledge, experience and best practice implementation across a broad EU MDR client base.


Programmatic Approach It is imperative that medical device manufacturers and other economic operators be proactive and adopt a programmatic approach to conformance. It is recommended that a cross-functional project team be formed to manage this Program. This Program should ensure that the following are addressed:

MAETRICS EU MDR PROGRAMMATIC APPROACH

+ Brief Executive Management to ensure they gain a clear understanding of the importance and business implications of the EU MDR;

+ Ensure that overall responsibility for EU MDR implementation has been established and that a cross-functional program team is formed in order to cover all aspects;

+ Study the detailed requirements of the EU MDR;

+ Perform a detailed gap analysis for products and the whole organization against the EU MDR requirements;

+ Give special consideration to certification expiry dates versus transition period and enforcement date;

+ Review the EU MDR implementation plan, identifying and addressing key areas of risk;

+ Consider organizational challenges: management awareness, staffing capability and availability, budget implications;

+ Continue to actively monitor the still-developing European Regulatory environment;

+ Check classification rules and confirm conformity assessment routes for existing and future products and take steps to address any changes;

+ Contact the selected Notified Body and determine their capacity and availability to service the implementation plan;

+ Review the changes needed in existing Technical Documentation (Technical File);

+ Determine the adequacy of clinical evidence and address any gaps (CERs);

+ Review the adequacy of Quality Management System (QMS) processes and the work done to transition to ISO 13485:2016, and build in the new regulatory requirements into the QMS;

+ Identify a Person Responsible for Regulatory Compliance (PRRC) and be sure they are adequately qualified and trained and plan their training, if applicable, as early as possible;

+ Review product labelling;

+ Ensure Product Liability provisions are adequate;

+ Ensure PMS arrangements are adequate;

+ Review supply chain provisions and clarify roles and responsibilities of business partners;

+ Prepare for unannounced inspections from Notified Bodies;

+ Ensure regular progress reviews of the EU MDR implementation program are held and included in the management review process.


Summary Conformance with the EU MDR is a significant business challenge that must be addressed in order to enjoy continued access to the EU market. To meet this challenge, manufacturers must be proactive and continue to prepare across the spectrum of EU MDR readiness activities.

Some of the underlying details of the EU MDR implementation process are not yet fully defined. Manufacturers must closely follow the emerging regulatory landscape, keeping alert for the detailed Implementing and Delegating Acts that are required in order to make the EU MDR operational.

In this challenging and competitive environment, the availability of resources is limited. Manufacturers are looking to third party specialists to plug the gap. In addition, executive support and proactive program management of EU MDR implementation is a prerequisite for a manufacturer’s success in this regard.

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