A proposal has been put forward to amend the transitional provisions for certain medical devices and in vitro diagnostic medical devices (amending Regulations (EU) 2017/745 (MDR)1 and (EU) 2017/746 (IVDR)2.
Amendments to these regulations have been prompted by factors which include the insufficient operating capacity of conforming assessment bodies as well as the unpreparedness of many manufacturers to meet the strengthened requirements of the MDR by the end of the transition periods. Taken together, there is the risk of shortages of medical devices on the EU market.
Continue reading Fantastic News – EU initiative: Extension of the transition period for medical devices