What is MDR 2017/745?

MDR 2017/745 refers to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. It establishes a new regulatory framework for medical devices in the European Union, replacing the previous directives. The MDR aims to ensure a high level of safety and health protection for patients and users by strengthening requirements for conformity assessment procedures, clinical evaluation, post-market surveillance, and traceability of medical devices. It also introduces new responsibilities for manufacturers, importers, distributors, and notified bodies.