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...
MD Regulatory transition under Brexit
With the UK having exited the EU in February 2020 (Brexit), manufacturers of medical devices and IVDs need to ensure they have plans in place to comply with the UK...
MDR – Some Class I Device Transitions Extended
Under growing pressure from industry and notified bodies, the need to provide some breathing space around Medical Device Regulation (MDR) deadlines by the European Commission has finally been considered. After...
