Medical Device Regulation

This directive, which is valid throughout Europe, defines the rules for medical devices. All mediCAD software solutions comply with this strict directive.

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

As of 26.5.2021, 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 2023, mediCAD® is MDR-certified.