Medical Device Regulation
The European Union Medical Device Regulation repeals the existing directives on medical devices: Medical Devices Directive and Active Implantable Medical Device Directive . The regulation was published on 5 May 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time of three years to meet the new MDR requirements.Summary
The date by which the Regulation was to be fully implemented by replacing the previous directives was originally defined as 26 May 2020. Following the international health emergency, the European Commission and the European Parliament decided in April 2020 to postpone the deadline by one year, until 26 May 2021.
