Medical devices and active implantable medical devices (AIMD)
Source: FAMHP
April 15, 2021
New Medical Device Regulation
As of May 26 2021, the European Regulation (EU) 2017/745 on Medical Devices (MDR) comes into force. The MDR introduces a major update of the regulatory framework in the European Union and brings about several changes to the scope of clinical investigations that must be submitted for approval, the submission processes for initial application and substantial modifications, submission dossier contents and safety reporting.