On 26 May 2022, the European Commission will roll-out the new in-vitro diagnostic regulation. One of the main changes in the IVDR is to increase the involvement of NBs. Under the current IVDD, less ...
The European Commission@s Medical Device Coordination Group (MDCG) on 20 May issued a @question and answer guidance to help the medical device industry comply with unique device identification (UDI) ...