Last week the European Parliament overwhelmingly voted in favor of the Commission proposal to amend the MDR. Even though this was just a vote in the first reading, it is now almost a certainty that the Date of Application of the MDR will be moved to May 26th 2021, as the Council has already confirmed that the Parliament’s first reading corresponds to what the Council would agree to. And because by necessity, this amendment has to enter into force before the 26th of May 2020, the usual 8 week consultation period for national parliaments has been skipped.
The amending regulation can be found here.
Recital 4 lays out the main reason:
Given the unprecedented magnitude of the current challenges, and taking into account the complexity of Regulation (EU) 2017/745, it is very likely that Member States, health institutions, economic operators and other relevant parties will not be in a position to ensure the proper implementation and application of that Regulation from 26 May 2020 as laid down therein.
While I fully agree that the MDR is complex, this should hardly be news to anyone in the Medical Devices industry. In fact, for companies that are taking their regulatory responsibilities seriously, implementation of the MDR should not be very complex, and most responsible companies were in fact as ready as they could be. It’s interesting how the Commission in recital 4 points to everyone except to themselves, although one could argue they are included in “other relevant parties” I suppose.
The fact of the matter is that it is in fact the Commission and the Member States that failed to ensure proper implementation by the original Date of Application. Common Specifications, Essential Guidance and implementing acts are late or delayed. Many member states do not have their implementing legislation ready. It all points to both the EU and the Member States underestimating and under-resourcing the MDR (and IVDR) implementation.
Will this move of the Date of Application by a year solve everything? Obviously it will give the EU and national authorities some time to get their act together. For manufacturers it’s a bit of a mixed bag. They will have less time to convert old (AI)MDD certificates to MDR certificates (three instead of four years), which might increase the likelihood of running into capacity problems with the Notified Bodies. On the other hand, it also limits the time during which no significant changes are allowed, which is a plus for innovation.
It is currently somewhat unclear what this means for Eudamed. In the current dates for Eudamed have also been moved one year, which raises the question whether the Commission intends to depart from its original plan to launch Eudamed at the Date of Application of the IVDR. The Commission promised in December of last year to clarify how to work with Eudamed in case it isn’t full ready yet after the Date of Application. We are still waiting on that.