The European Commission has published an overview of the information that will be publicly available under EP and Council Regulation (EU) 2017/745 on medical devices.
On the 9th of July 2020 the European Commission has adopted a Communication to help national authorities, businesses and citizens prepare for the inevitable changes.
Due to the corona crisis the majority of the clinical trials conducted were put on hold. Since the Dutch Government currently gradually reduces the restrictive measures.
The European Commission’s Medical Device Coordination Group (MDCG) issued guidance explaining the process for transitioning CE certificates
The AEMPS extends the deadline until May 25, 2021 for the adequacy of the labeling and the instructions for use of medical devices as a consequence of the changes made by Brexit