Commission Invites European Standards Bodies To Accept MDR/IVDR Standardization Request

The European Commission has at last officially requested that CEN and CENELEC develop and update urgently needed standards to support the MDR and IVDR. The pressure is now on the national European standards bodies to press on with the necessary work.

The legal basis to draft and revise harmonized standards for the EU Medical Device Regulation (MDR) and the IVD Regulation (IVDR) is due to be accepted by the European standards bodies, CEN and CENELEC, by 17 June.

The European Commission has announced that it has adopted the standardization request for CEN and CENELEC. It notified them...