Europe
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical device regulation, published guidance aimed to assist medical device manufacturers facing notified body withdrawals. According to the guidance, if a notified body...
EU MDR/IVDR
The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. This is a crucial process and should be carried out by Notified Bodies. Notified Bodies: Legal Status The new framework introduced by these...
Europe
The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued a final version of the assessment form intended to be used by designated authorities to select a notified body. Notified Bodies and Conformity Assessment Bodies The MDCG, an...
