European Directives and Regulations

Current Directives on medical devices

Medical devices within the EU are currently regulated by 3 directives:

New Regulations on medical devices

On 5 April 2017, 2 new regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746) were adopted. They entered into force on 25 May 2017 and will progressively replace the existing directives. The new regulations will be fully applicable in May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.