It is no surprise, but there are major concerns regarding whether the industry is ready for the transition period to end for ‘legacy’ devices. As reported in MedTech Dive, several industry groups have called for an extension.  

The reason for the concern? 

While the MDR date of application occurred on 26 May 2021, most of the devices actively being placed onto the European market are still CE Marked to the old Directives, and not the MDR.  

Legacy devices are allowed to be on the market due to the transition provision in Article 120(3) of the MDR. However, that transition period ends 26 May 2024, two short years from now. Further, there’s only an additional one year after, in which those devices can continue to be put into service. Under current legislation, 26 May 2025 is the end of MDD/AIMDD CE Marked devices on the European market.  

In the meantime, MedTech Dive’s article cites that less than 1,000 MDR CE Certificates have been issued — of the 25,000 MDD certificates that need MDR CE Marking. This means with only two years left to convert to the MDR, less than 5% of the medical device industry is ready. 

Additional Complications? 

There are only 27 Notified Bodies (NBs) accredited to the MDR, compared to the 50 accredited to the MDD. All are listed in the NANDO database.

Further, due to the added complexity of the MDR and resource constraints, the average timeframe to CE mark is 18 months. This means every company that hasn’t already, must start MDR CE marking within the next six months to prevent a gap between their MDD and MDR CE Marking. And based on the current number of NBs, each one must take a little under 1,000 clients within that timeframe. This does not include new devices being introduced to the market.

As well, NBs are struggling to maintain sufficient resources. As many manufacturers have already faced, there is a long lead time before some NBs can take on new clients.

Add those elements together, and the petition for a lengthier transition is not only logical, but necessary.

Will the transition period postponement be granted? 

Based on the above numbers, the EU Commission will need to give it serious consideration. And presumably already has. That said, we expect that, like the EU Commission’s postponements related to EUDAMED, the MDR and the IVDR, we will not know until we get closer to the compliance date.