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INDUSTRY NEWS BRIEF: Don’t Misinterpret the New MDR Extension
It is official. The European Parliament has passed the proposal originally introduced last December to extend the implementation of MDR for ‘legacy’ devices & IVDs (i.e. that have active certificates under MDD, AIMDD, and IVDD). Its goal is to help avoid devices being removed from the European market for regulatory reasons and due to the expected rush on Notified Bodies to keep certificates active, and the extension became formal when it was published in the Official Journal of the EU. Details and background can be found here, or the new regulation itself (EU 2023/607) can be reviewed here.
Key highlights of the extension:
- Class I-II devices requiring Notified Body involvement will now allow for extensions of existing certificates (under MDD/AIMDD) until the end of 2028, and end of 2027 for Class III. This includes provision for extension of validity of certificates issued prior to 26 May 2021 (the date of application of the MDR).
- To apply, the manufacturer must have applied for MDR CE-marking prior to 26 May 2024 (the original certificate validity cutoff), or a competent authority must have issued a derogation (which is currently allowed per Art 97 and is the subject of recent MDCG guidance).
- No significant changes are allowed, and the devices must “not present unacceptable risk to the health or safety of patients, users or other persons…”
- The manufacturer must put in place a Quality Management System (QMS) in accordance with MDR Art 10 by 26 May 2024.
- Ongoing surveillance is still performed by the Notified Body; however, there are provisions to allow transfer to a different Notified Body than issued in the original MDD certificate.
- The ‘sell off’ date will be removed, thus allowing sale of any devices placed on the market prior to the new cutoff dates listed above (this was previously 1 year after the final transition date, which would have been 26 May 2025). Expiration dates for most devices will still control the availability of inventory, but the artificial regulatory cutoff will be removed.
- This will not have a direct impact on combination product developers who have ‘single-integral’ combination product as MDR Art 117 (requiring an NBOp) is not affected by these provisions and has been in full effect since 26 May 2021. But, this will be important to note for the many developers pursuing ‘co-packaged’ systems and, of course, any companies with direct device CE-marking needs.
The bottom line is that, although this does provide for an extension in the date of application and allows continued marketing of devices CE-marked under MDD/AIMDD/IVDD, it’s not just a straight-up extension of current certificates. The MDR applications must still be submitted by May 2024, plus postmarket surveillance and QMS provisions of MDR must be followed. Companies must still be undertaking significant activities for the implementation of MDR (and IVDR), so one should be careful not to misinterpret this change.
If you are looking for more information on this topic, the Regulatory Affairs Professionals Society (RAPS) has very good coverage.
Jonathan Amaya-Hodges, Director, Technical Services, Suttons Creek, Inc. – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.