MDR 745/2017
The EU MDR 745/2017 is an European Union regulation to ensure safety, quality and performance of medical devices. Officially published in May 2017 and fully applicable as of May 26, 2021, replacing the Medical Device Directive (MDD) and introduced stricter requirements for clinical evaluations, documentation, and post-market surveillance. For better traceability it enforces the use of Unique Device Identification (UDI) and promotes transparency via the EUDAMED database. Moreover, it reinforces the responsibilities of Notified Bodies.
Latest updates relating medical devices can be found on the official site of the European Union, which can be found under this link: https://health.ec.europa.eu/medical-devices-sector_en
New regulations relating medical devices: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
