State of Play and Implementation of the EU Medical Device Regulation

    View Author July 2019

    Introduction 

    The new Medical Device Regulation (2017/745/EU) (the Regulation) represents the most radical shift in EU regulation of medical devices for decades. 

    Regulation 2017/745 was adopted by the EU in May 2017 and is to replace existing EU legislation dating back to the 1990s. These are the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC). 

    The Regulation is designed to increase the health and safety protection of EU patients, add more control and oversight in the system, and adapt to new technologies and scientific progress in the medical device sector.