Countless industries are finding themselves under increased pressure throughout the global COVID-19 Pandemic due to the unavailability—or significant reduction—of resources owed to illness, self-isolation, stringent social distancing measures and re-deployment of staff to the most critical activities that support our global healthcare system.
Those involved in medical device design and development, quality and regulatory processes, and conformity assessments of medical products in the EU have rapidly diverted efforts to projects enabling increased production of essential medical devices such as ventilators. Understandably, the medical devices industry is unable to focus efforts towards the fast-approaching current date of application of Regulation (EU) 2017/745 on medical devices (MDR) of 26 May 2020.
On 3 April 2020, the European Commission published the proposal, ‘Regulation of the European Parliament and of the Council: amending Regulation (EU) 2107/745 on medical devices as regards the dates of application of certain of its provisions’, found here. This document proposes a delay to the date of application of certain provisions of the MDR by one (1) year to 26 May 2021.
Key Considerations for Medical Device Manufacturers*:
- Surprisingly, there is ambiguity regarding the proposed changes and how they relate to the ‘grace period’. Since there are no proposed amendments to Article 120 section 3, which itself was the subject of a re-write under the second corrigenda (referred to as ‘C2’ in the consolidated version of the MDR in late 2019), it could be concluded that manufactures still need to meet specific MDR requirements. These include making no significant changes to device design or intended purpose, and meeting requirements for post-market surveillance, market surveillance, vigilance and registration of economic operators, by 26 May 2020.
- The ambiguity described above might not change the date of application in relation to some class I devices, where the previous benefits of the second corrigenda to the MDR may remain unchanged, and therefore the date of application of 26 May 2020 might still apply. The MDR compliance timeline has been compressed by one (1) year, not merely extended.
- Notified Bodies may be able to conduct additional Directive 93/42/EEC activities concerning medical devices (MDD) certificate renewals until 25 May 2021, which would allow some manufacturers unable to secure certificates by 25 May 2020 the opportunity to use the grace period. However, the self-isolation and social distancing measures brought about as a result of COVID-19 have already impacted Notified Bodies and as such, they are only offering remote assessments. This may pose challenges for some manufacturers due to the inability to conduct on-site renewal assessments where absolutely necessary.
- Key MDD certificate validity dates of 27 May 2022 and 27 May 2024 have not changed.
- The ability to continue to put MDD certified devices into service until 26 May 2025 would not change under this proposal.
*This is still only a proposal, and therefore, is subject to change.
MDR Article 120 Section 3: The ‘Grace Period’ May not be Affected
Notably, the European Commission proposal covers some provisions under MDR Article 120, but not those of section 3 (commonly referred to as ‘the grace period’). The second corrigendum (‘C2’) of the MDR included specific dates for devices under certain circumstances (whereas the original text of Article 120 section only referred to “…the date of application of this Regulation…”):
“3. By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph 2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. 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.”
Since there is no proposal to amend these dates, it may be concluded that manufacturers should continue their compliance efforts to meet Article 120 section 3 by 26 May 2020.
Other Unaffected Dates Include:
- 27 May 2022: where certain MDD and AIMDD certificates issued prior to 25 May 2017 become void.
- 27 May 2024: where certain MDD and AIMDD certificates issued from 25 May 2017 become void.
- 26 May 2025: the date after which no devices lawfully placed on the market under MDD can be put into service.
Proposed Delays:
- Notified Body designation to Directive 93/42/EEC concerning medical devices (MDD) and Directive 90/285/EEC relating to active implantable medical devices (AIMDD) to become void on 21 May 2021.
- It is not clear how each Notified Body would choose to spend this additional year, although it is likely that they will endeavor to continue to focus on conducting existing manufacturer certificate renewals. However, some might use this as an opportunity to conduct initial MDR reviews.
- It is recommended to contact your Notified Body as soon as possible to discuss your MDD and MDR certification needs on a case-by-case basis.
- Common specifications will not be adopted until 21 May 2021.
- Verification of the functionality of EUDAMED, and publication of a notice to that effect in the Official Journal of the European Union, has a one (1) year extension.
- Ensuring that until 25 May 2021, (i.e. during the period where the MDD and AIMDD continue to apply) competent authorities can continue to permit devices that are in the interest of public health or patient safety/health to be placed on the market without the need to meet the conformity assessment procedures of those Directives.
- This clause has never been so important, during the COVID-19 Pandemic, as European governments and industry seek to provide medical devices to patients and front-line healthcare workers, where time is of the essence.
- Notification of Member State penalties for infringement of the MDR delayed from 25 February 2020 to 25 February 2021.
- The European Commission proposal clarifies that Notified Bodies, designated to MDR, may still issue MDR certificates prior to the new date of application of 26 May 2021.
Conclusion
Prior to the global epidemic of the COVID-19, medical device industry stakeholders were faced with significant workloads as they each endeavored to meet the challenges of MDR (manufacturers, economic operators, Notified Bodies, Designating and Competent Authorities). These challenges concerned both the short-term urgency to complete MDD and AIMDD certificate renewal audits, as well as the implementation of processes by 26 May 2020 to make full use of the MDR Article 120 section 3 grace period.
The proposed delay to the date of application of certain provisions of the MDR to 26 May 2021 is welcomed by stakeholders, as there is a worldwide effort to ‘flatten the curve’ of COVID-19 to help ensure the immediate delivery of vital medical devices to patients and healthcare workers.
The full benefits of a one (1) year extension will likely be significantly hampered by self-isolation and social distancing measures currently underway around the globe. Notified Bodies will, no doubt, be limited to only performing remote audits, which is some cases might not be adequate. In this rapidly developing global crisis, it is vital that stakeholders closely monitor the progress of this European Commission proposal for a delay to certain provisions of the MDR. Once ratified, it is recommended that manufacturers speak to their Notified Bodies regarding how this could affect the ability to make best use of the MDR grace period, and how it will affect specific MDR transition plans.
Finally, it is hoped that the potential ambiguity regarding the text of the second corrigenda, in relation to Article 120 section 3, will be reviewed whilst this proposal is under further consideration. This is needed in order to clarify whether or not there are some conditions that still might apply from 26 May 2020 despite the date of application for other provisions (26 May 2021).
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers.
Additionally, NAMSA provides support to market authorization holders, including implementation of MDR requirements, MDR/IVDR conformity strategies and compilation of appropriate technical documentation for submission to Notified Bodies.
Learn more about NAMSA’s MDR resources here.
Matt Royle
Matt supports medical device clients worldwide to understand and meet the regulatory requirements in the EU. He has over 15 years’ experience in medical device research, product development and regulatory affairs. He has experience in start-ups, medium-sized and multinationals, bringing new products to market and supporting existing portfolios, and providing leading roles in advising and implementing EU regulatory strategy. He worked as a Notified Body Product Specialist for a number of years, specialising in conformity assessment of implantable class III and IIb orthopaedic joint replacement and sports medicine, spinal, and bone grafting devices, as well as associated class IIa instruments. Matt has a Master’s degree in Mechanical with Medical Engineering from University of Leeds, a PhD in orthopaedic biotriobology from Queen Mary, University of London, and is a Chartered Engineer with the Institution of Mechanical Engineers.
Adrian Keene
Adrian is Director of EMEA Consulting Services at NAMSA where he utilizes his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He is responsible for new product development using EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products. Adrian previously Head of Notified Body of SGS in the UK, and also served as the Global Clinical Affairs and Regulatory Manager for Medical Devices (SGS) with responsibility for conformity assessment activities of high-risk (Class III) devices under the Medical Devices Directive (MDD). In all, Adrian has 25 years’ experience in the medical device industry. He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.