The European Parliament has voted overwhelmingly to extend transition periods for the Medical Device Regulation (MDR). The Parliament also approved the removal of the “sell-off” provisions from the MDR and In Vitro Diagnostic Device Regulation (IVDR).
The MDR transition period had previously been set to end in May 2024. The extension means that medical devices CE marked under the old Directive-based system will now continue to be accepted on the EU market until:
As a result, manufacturers now have more time to obtain updated CE marking under the MDR. This extension is seen as necessary due to the volume of devices that still need to transition over to the MDR system (estimated to be around 23,000 devices) and limited Notified Body capacity to process these applications. Extending the transition period allows for more time not only to work through the applications but also to designate new Notified Bodies to help deal with the increased demand.
In addition to extending the MDR transition periods, the European Parliament also voted to remove the “sell off” provisions from both the MDR and the IVDR. These provisions would have required manufacturers to withdraw devices which are already in the supply chain but which have not yet reached their end users before the end of their transition period. Providing reasonable efforts have been made by the manufacturer to obtain MDR certification, Member States can now extend the old Directive-based certificate on a case-by-case basis.
Approving these proposals was seen as particularly urgent due to concerns over the perceived risk of medical device shortages resulting from the transition over to the new MDR and IVDR. The European Parliament announced that it would forgo its usual 20 day waiting period before publishing the amendment in the Official Journal of the European Union. Once published, the amendment will take immediate effect.
[1] There is no extended transition period for Class I devices as the MDR has applied since May 2021 to these products