Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – also known as MDR and IVDR, respectively – revised the regulatory framework focusing on medical devices and in vitro diagnostic medical devices.
They sought to ensure a high level of protection of health for patients and users and the smooth functioning of the internal market for these products. To achieve these objectives and, in light of issues identified with the previous regulatory framework, the Regulations set out a more robust system of conformity assessment to ensure the quality, safety, and performance of devices placed on the EU market.
