Recommendations for a targeted revision of EU medical devices rules

Consumers use a wide range of medical devices in their daily lives to walk, keep their heart beating, or check their glucose levels for instance. If the performance of these products is low, they can disrupt consumers’ health and quality of life. 

Ensuring that devices are safe, effective, and available for consumers contributes to the EU’s healthcare quality. This calls for better pre-market assessment and market surveillance in the EU, and adequate shortage prevention and mitigation measures. It also means that consumers should have access to clear information and adequate shortage and safety reporting mechanisms to communicate with public authorities. 

This document compiles BEUC's recommendations for targeted revision of EU medical devices rules after the EU's public consultation on medical devices rules.