European Health Union :Helping the transition to the new rules on medical devices and in vitro diagnostics

In 2017, the EU introduced new rules for medical devices and in vitro diagnostics to ensure a better protection of public health and patient safety. Despite considerable progress in transitioning to these rules and the additional time given to the sector to implement them, the transition remains slow. In 2023, the Commission took measures to ensure the availability of medical devices and is now proposing taking additional steps to ensure the availability of high risk in vitro diagnostics by May 2025. The priority is to ensure that patients have access to safe and qualitative medical devices and in vitro diagnostics.