Device Group Raises Alarm Over MDR Transition

Time is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe said in a new call to action. 

The biggest challenge is the shortage of notified bodies for certification as only nine have been MDR-designated and 55 notified bodies are still awaiting their MDR designation.

Capacity at the nine MDR-designated notified bodies “is extremely limited, putting at risk the continued availability of existing devices,” the association said.