Update on Notified Bodies designation under MDR / IVDR
The implementation of the new European MDR (2017/745), now in place since May 2021 and IVDR (2017/746) less than a year away, has proven to be a very challenging task...
EUDAMED is LIVE
The Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 include use, maintenance and management of a European databank on medical devices (EUDAMED). The database consists of...
Europe’s pragmatic approach to clinical evidence for legacy devices – or why the devil is always in the detail…
Regulatory affairs demand attention to detail. So when the European Medical Devices Coordination Group released document MDCG 2019-3 - Interpretation of Article 54(2)b we regulatory geeks just knew we should...
