Medical Device Regulation

EU Regulation for Medical Products (2017/745/EG)

As of 25.5.2017, the new European Medical Device Regulation MDR came into force. It defines from now on the requirements for the conformity assessment of medical devices and combines and replaces two previously independent medical device guidelines. As an European regulation, as opposed to European directives, the Medical Device Regulation must be applied within a period of 3 years as a European supranational law.

As of the beginning of 2023, mediCAD is MDR-certified.