Regulation

Regulation

Views on the rules and regulations that govern MedTech.

Director of IVD Operative Unit of Notified Body 0373 Italian Health Institute (ISS)
The new EU In Vitro Diagnostic Medical Devices Regulation (IVDR) was published in May 2017. While the IVDR has a five-year transition period (longer than the...
Executive Director, European Alliance for Personalised Medicine
For me, one of the most intriguing health policy questions of our time is how to encourage citizens to embrace healthy lifestyles. Should we tax and punish bad...
Senior Vice President Global Medical Devices, BSI Group
W ith 45% of devices accessing the EU via UK NBs, what would be the impact of a so-called “hard Brexit?” The political landscape is far from clear. However,...
Senior Vice President Global Medical Devices, BSI Group
It is now circa ten months since any well-prepared Notified Bodies (NB) wishing to undertake conformity assessment under MDR (EU) 2017/745 and IVDR (EU) 2017/...
New Medical Device Regulation – an obstacle to progress
Member of the Management Board, B. Braun Melsungen AG
On May 25 th , 2017, a new era began. The date marks the beginning of the Medical Device Regulation, the MDR in short. It provides a new framework for the...