Revisions of Medical Device Directives

On 5 April, the European Parliament and the Council are adopted two new Regulations on medical devices: Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The new rules will only apply after a transitional period: 3 years for medical devices (spring 2020) and 5 years for vitro diagnostic medical devices (spring 2022).