French, German medtech groups call for at least 2-year extension of MDR’s transition period (MedTechDive)
Dive Brief:
Two of the European Union’s most important medtech associations, France’s Snitem and Germany’s BVMed, are calling for at least a two-year extension of the EU’s Medical Device Regulation transition period, slated to end in May 2024.
BVMed and Snitem, whose members account for over 50% of the EU medical device market, in a joint statement warned that the postponement of the MDR transition period is critical if a “collapse in patient care” is to be prevented. “The two-stage extension of the transition period by two years for higher classified products (class III and implantable products) and by four years for all other products is intended to ensure the availability of medical products with the resources currently available,” the medtech groups said.
While the MDR has been in effect since May 26, 2021, BVMed and Snitem contend that the “only partially operational” regulations are tying up too much of the medtech industry’s scarce resources as well as the limited current capacity of the 27 notified bodies (NBs). Trade...
