Brace for Impact: The New MDR Transition Periods
It has been much discussed and we covered it in our newsletter before: now - drum roll - the MDR deadline has been finally postponed once again. The European Parliament voted on the Commission’s proposed changes in February, the European Council voted on March 7th. Next, the adopted changes will be published in the EU’s official gazette in the upcoming days and take effect immediately.
This means, in simple language, that manufacturers and Notified Bodies will be given more time for the certification of their medical devices according to the MDR. But how much time exactly? What will be the new deadlines for which device classes? We wished there was a simple answer (in fact, the chaos is even more complex than we thought), but we will try to boil it down for you.
It’s All About Legacy Devices
Let’s start simple: the extended transition period applies only to legacy devices (i.e. those devices covered by a NB certificate or declaration of conformity according to MDD prior to May 26th 2021). If you just finalized the development of a new device, you will have to go through the whole hamster wheel of MDR certification.
Removal of Sell-Off Dates
Great news next: the end date of May 26th, 2025 for MDD devices has been removed altogether. Previously, products that were placed on the market before or during the transitional period had to be withdrawn before the “sell-off date” specified in Article 120(4) MDR. And yes, you did read that correctly: those devices can now stay on the market indefinitely - without any legal time restriction. The removal of a deadline is intended to ensure that safe medical devices continue to stay available beyond May 2025, according to the European Commission.
Of course, note that such devices can only continue to stay on the market. That does not mean that new MDD-based certificates or declarations of conformity should be issued. You should also uphold MDD conformity of those devices, avoid significant updates and unacceptable risks. The next paragraph might give you some more guidance.
Previously Class I MDD: The Case of Rule-11-Devices
Everybody was at first shocked to read the new MDR classification rules and especially rule 11. Now, even software that merely provides information for diagnostic or therapeutic decisions would fall into class IIa, instead of class I as in most cases before. As we’ve discussed before, it turned out that there is still a chance for class I software under the new MDR rules.
However, for “unlucky” devices - previously class I MDD but presumably class IIa MDR - the adopted changes did not replace the old deadline by a new one, but by three new ones!
Bear with me: MDD class I devices which now require the involvement of a Notified Body for MDR certification may now be kept on the market until 31 December 2028 according to the updated Article 120(3) MDR. This extended transition deadline is subject to the following conditions:
- The devices must continue to comply with the MDD;
- There must not be any significant changes to the design or intended use;
- The devices must not pose an unacceptable risk to the health or safety of patients, users or others;
- The manufacturer must have established an MDR-compliant quality management system (Art. 10, para. 9 MDR) and submitted a formal application with a Notified Body for MDR conformity assessment by May 26th, 2024 at latest;
- The manufacturer and the Notified Body must have signed a written agreement by September 26, 2024.
The entire purpose of these complicated madness is obviously that, in order to benefit from the extended transition periods, medium- to high-risk device manufacturers should demonstrate to have taken first steps moving towards full compliance with EU MDR requirements.
The New Transition Deadlines, Including High-Risk Devices
So finally, here’s an overview of the new extended deadlines:
- Class III devices and class IIb implants must transition before December 31st, 2027
- Class IIb devices and class I* devices (incl. 1s - in sterile condition, 1m - with a measuring function and 1r - reusable surgical instruments) must transition before December 31st, 2028
- Class III custom-made product must transition before December 31st, 2026
The requirements described above on applying for MDR certification before May 2024 and signing a Notified Body contract apply respectively also for high-risk devices. There’s still more complicated exceptions for so-called “well-established technologies” (class IIb implants like dental braces or fillings), for example, but we won’t go into that. It’s complicated enough as it is.
Finally, you can also read up yourself on the European Commission’s considerations for these changes on their Q&A website. Good luck!