EU Proposes MDR Deadline Delay

The EU is considering a proposal to delay by several years the compliance deadline for its Medical Device Regulation (MDR) which was to go into effect May 26, 2024, as there are insufficient resources to meet the deadline required by law.

The MDR requires that manufacturers get their medical devices recertified by non-governmental “notified bodies” or remove the device from the marketplace, leaving EU states with potential critical shortages of medical supplies. But there are only 36 notified bodies certified to perform all the required audits and they estimate that the number of MDR certificates issued by May 2024 may reach only 7,000 at the current rate. More than 22,000 certificates are expected to expire by May 26, 2024.

Staggering deadlines based on the risk class of the device is one option under discussion with higher risk class III and class IIb deadlines of 2027, and 2028 for lower risk class IIa and class I as well as extending the expiration of the validity for certificates currently issued.