Further to our discussion on the European Commission’s proposal to extend the transition period under the Medical Devices Regulation (EU) 2017/745 (MDR), the Commission has adopted a formal proposal for a legislative amendment of the MDR and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) and published a press release, Q&A and factsheet on the proposal. The proposal does not introduce any substantive changes to the broader MDR but focuses on amending the transitional provisions in the MDR.

The proposed changes to the MDR transition provisions aim to address concerns regarding Notified Body capacity and the significant number of medical devices yet to transition from the former Directives to the MDR. This situation is currently threatening the availability of such devices within the EU market.

In essence, the proposal extends the period companies have to obtain MDR-compliant certificates and also provides more time for Notified Bodies to clear the backlog in their conformity assessments.

The main elements addressed in the proposal are:

  • For medical devices approved under the Medical Devices Directive 93/42/EEC (MDD) or the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) covered by a certificate or a declaration of conformity issued before 26 May 2021, the relevant transition periods will be extended:
    • to 31 December 2027 for high-risk devices (class III devices and for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors); and
    • and to 31 December 2028 for medium and low-risk devices (class IIb devices other than those covered in the foregoing point, for class IIa devices, and for class I devices).
  • The extensions set out above will only apply to devices that are considered “safe” and for which the manufacturers have taken steps to transition to the MDR (initiate MDR conformity assessment and implement a QMS both no later than 26 May 2024).
  • The transition period for class III implantable custom-made devices will be extended to 26 May 2026, subject to the manufacturers of such devices applying for a conformity assessment before 26 May 2024.
  • To allow for the above, the proposal will extend the validity of certificates issued under the MDD prior to 26 May 2021 (the date on which the MDR became applicable).
  • The removal of the “sell-off”-deadline established in the MDR and the IVDR, after which MDD/IVDD/AIMDD-certified medical devices already placed on the market had to be withdrawn. This will ensure that healthcare systems and patients will continue to have access to safe and crucial medical devices that are already on the market.

The proposal obviously gives the medical device industry more time to transfer their devices from MDD (and AIMDD) to the MDR. This also reduces the capacity issues of the Notified Bodies. Nevertheless, the extended timelines only apply if certain conditions are met and these include that the manufacturer company must have applied for the MDR-based conformity assessment with a Notified Body no later than 26 May 2024. Further, the manufacturer must have put in place a quality management system in accordance with the MDR no later than 26 May 2024. Hence, despite the extended timelines there is still a lot of work to do for device companies and the Notified Bodies.

Even though the new extended timelines would provide device manufacturers some relaxation, it still remains to be seen whether they will be sufficient in light of the significant implementation issues of the MDR.

The proposal also clarifies that the MDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to the above “extended” devices in place of the corresponding requirements of the MDD and AIMDD.

As discussed in our separate blog last month, the EU’s Medical Device Coordination Group (MDCG) released new guidance (MDCG 2022-18) on the use of the non-compliance procedure under Article 97 of the MDR for devices that do not yet comply with the MDR. Article 97 MDR, even if not designed for these MDR transition and implementation issues, formally enables such medical devices to continue to be available on the market if they do not pose an unacceptable risk to the health or safety of individuals or to public health. In the EU Member States, manufacturers and regulatory authorities have already been discussing the Article 97 MDR route ahead of this new MDCG guidance as a means to cope.  

The new proposal, along with the MDCG Article 97-MDR-guidance, shows that the European Commission is working towards resolving the issue of the large number of devices yet to transition to the MDR. As noted, the proposal also “helps” the diagnostics industry by removing the sell-off period from the IVDR. The need to transition (a huge number of) IVDs from the IVDD to the IVDR will likely cause an even more delicate regulatory situation than the device industry has been facing with the MDR. In particular, the diagnostics industry and pharmaceutical companies engaged in companion diagnostics (CDx) should take steps as early as possible to secure compliance with IVDR.

As to next steps, the proposal now has to be adopted by the European Parliament and Council, using an accelerated co-decision procedure. The Covington medical device team will continue to monitor this process and provide further updates.

Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and software technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah has particular expertise in advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, and is the Graduate Recruitment Partner for Covington’s London office.

Sarah regularly advises on:

  • classification determinations for software medical devices, including on developments resulting from the implementation of the EU Medical Devices Regulation;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah’s pro bono work includes advising the Restoration of Appearance and Function Trust (RAFT) on the classification of a wound healing product containing human blood derivatives, and assisting in a project aimed at improving regulatory systems for clinical trials of drugs and vaccines for neglected diseases in developing countries.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah has undertaken several client secondments, including to the in-house legal department of a multinational pharmaceutical company.

Maria Oliveira

Maria Oliveira is a Trainee Solicitor who attended the University of Law and BPP University.

Photo of Dr. Dr. Adem Koyuncu Dr. Dr. Adem Koyuncu

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is…

Adem Koyuncu is double qualified as a lawyer and medical doctor and a partner in our Brussels and Frankfurt office. He is a chair of the firm’s “Food, Drug & Device” practice group and also a member of our Compliance practice. Adem is recognized as a “leading lawyer for pharma and medical devices law” (JUVE 2021).

Adem helps clients on a wide range of EU and German law issues, including regulatory, compliance, privacy and liability matters. He also provides strategic advice. He knows the life sciences sector also from his earlier work in the pharmaceutical industry and as a medical doctor. He represents clients before courts and authorities and assists them in contract negotiations, investigations and transactions. For years, Adem is listed in various lawyer rankings.

See some Accolades from Clients and Surveys:

  • “He is one of the most detail-oriented and client-focused partners I have ever encountered.” (Client, Chambers 2021)
  • „Great professional and human competence, good team player.“ (Client/Adverse Party, JUVE 2022)
  • “I find him to be one of the most pragmatic regulatory lawyers. He was a doctor before a lawyer, has been in-house, worked on lots of stuff that I have to handle in-house, which helps when getting advice. He is really good at saying it’s a complex situation and your best option is to do this.” (Chambers 2022)
  • “He always comes through with extremely helpful advice. He brings a unique understanding and experience to his practice as both a lawyer and medical doctor.” (Chambers 2021)
  • “Adem Koyuncu is not only a lawyer but also a doctor and has worked in industry. He knows the perspectives that also move in-house lawyers.” (Legal 500 2022)
  • “He is very sharp and quick, while at the same time having a good sense of humor and nerves of steel. Very pleasant to work with.” (Legal 500 2022)
  • He is described as “versatile competent, reliable and high quality” (JUVE 2021) and “incredibly fast.” (JUVE 2018)
  • Provides advice at “an outstanding level.” (Legal 500 2015)
  • “Very strong negotiation skills.” (JUVE 2011)
  • Clients appreciate his “very broad knowledge and long-standing expertise” (JUVE 2021/22) and that “he is approachable, knowledgeable and really easy to talk to over the various issues. He is calm and has seen most problems before.” (Chambers 2020)
  • Peer lawyers described him as “highly competent” and a “very good and pleasant lawyer” (JUVE 2014) and as “the off-label-guru, substantively very good, creative.“ (JUVE 2022)

Adem is the author of numerous publications (e.g., in leading books on pharma law, product liability and clinical trials) and frequent speaker at different events. As such, he will soon speak at following events:

  • “Medical Device Liability and Risk Transfer 2.0 | A liability issue for the Management?!,” BVMed, Webinar (3/24/2023)
  • “Data Protection Requirements and Open Issues in the Pharma Sector – Status quo,” Speech at conference, 26. Marburger Gespräche zum Pharmarecht, Marburg (3/16/2023)
  • “Vendor Oversight & Vendor (Quality) Management in the Pharma Industry,” FORUM-Institut, Online Seminar (4/19/2023)