European Commission Puts the Delay to EU MDR Transition Timelines to the Vote
The MedTech industry is facing huge problems in implementing the EU MDR with capacity constraints and bottlenecks with notified bodies. Currently only 36 notified bodies are designated to the EU MDR and another 26 are in application. The capacity available for conformity assessments is impacting manufacturers’ ability to place medical devices on the EU market, leading to the risk of shortages in much needed medical devices.
Additional challenges like manufacturers not being sufficiently prepared for the changes in the regulation, post Covid-19 pandemic impacts on clinical investigation and on-site audits and the conflict in Ukraine effecting global supply chains is not helping either. These challenges are hurting the most important stakeholders; the patients and users of these medical devices.
The European Commission’s proposal paper was produced after the EPSCO meeting on December 9, 2022 where the European Commission proposed new transition period extensions for the EU MDR to support the rising pressures on the MedTech industry. It amends Article 120(2) of the EU MDR to extend valid MDD and AIMDD certificates from the date of application of May 26, 2021 until the new transition timelines (provided they have not been withdrawn by a notified body).
The position paper provides further clarification on the new transition extensions to fully comply with the EU MDR as well as outlining some important caveats:
- High risk Class III and Class IIb implantable devices will have until December 31, 2027 to comply with the EU MDR (except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors)
- Medium and Lower risk such as some selected Class IIb, Class IIa and Class I devices will have until December 31, 2028 to comply with the EU MDR
- Class III implantable custom-made devices will have until May 26, 2026 to comply with the EU MDR (but manufacturers must apply for a conformity assessment with their notified body by May 26, 2024)
- Removal of the sell-off provision in Article 120(4) MDR and Article 110(4) IVDR of May 26, 2025 means devices placed on the market before the end of the transition period can be made further available without a legal time restriction
- Applications for EU MDR conformity assessment are submitted by May 26, 2024 for legacy devices in accordance with annex VII
- Only manufacturers with valid MDD/AIMDD certificates (these are still subject to unannounced surveillance audits) and those who have taken reasonable steps to transition to the EU MDR will be granted the extended timelines
- There are no significant changes in design or intended purpose of medical devices (if so, manufacturers must automatically transition to the EU MDR)
- The devices do not post any unacceptable risk to health and safety, patients and users
- A Quality Management System (QMS) is in place by May 26, 2024
Our Advice and Next Steps
We advise medical device manufacturers NOT to slow down in their transition plans as there is still a huge mountain to climb to gain your EU MDR conformity. Although the European Commission’s proposed extension of transition timelines may provide some short-term relief to the MedTech industry, the amount of work needed by manufacturers and notified bodies remain.
Our regulatory experts will support you with preparing technical files for notified body conformity assessment, creating and updating clinical evaluation reports, training and education, and lots more.