The EU rules on the safety and performance of medical devices were created in the 1990s. In April 2017, the European Parliament and the Council adopted Regulation (EU) 2017/745 and Regulation (EU) 2017/746 to reinforce the regulatory framework for medical devices and in vitro diagnostic medical devices. The objectives of these Regulations are to achieve a high level of protection of health for patients and users and to ensure the smooth functioning of the internal market for medical device 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…
