Brace for Impact: The New MDR Transition Periods
Brace for Impact: The New MDR Transition Periods
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
Removal of Sell-Off Dates
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
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 New Transition Deadlines, Including High-Risk Devices
- Class III devices and class IIb implants must transition before December 31st, 2027
- Other class IIb devices, class IIa 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
Finally, you can also read up yourself on the European Commission’s considerations for these changes on their Q&A website. Good luck!
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Sven Piechottka
I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.