EU – implementing regulation for EUDAMED database published
The EU Commission has published an implementing regulation relating to the EUDAMED database. This governs general questions, e.g. relating to access and registration.
EU: Additional EUDAMED modules approved
EU: Expert committee for IVD begins work
Since the start of September, the expert committee for the IVDR has been accepting requests from notified bodies for consultation procedures relating to performance evaluation. An overview of the expert committees for the Medical Device Regulation and in-vitro diagnostics directive can be found here.
EU: Additional corrigenda in different language versions of the MDR
In July 2021, the EU updated several language versions of Regulation (EU) 2017/745 (MDR) in the form of additional corrigenda, including the German version. The most recent update corrects more than 50 translation errors. A consolidated version of the MDR with notes on the changes can be found here.