On Wednesday 23 October in Strasbourg, the European Parliament voted in favour of revising the rules on medical devices available on the EU market (contact lenses, pacemakers, etc.).
In adopting a joint resolution by the EPP, S&D, ECR, Renew Europe and Greens/EFA on the urgent need to revise the Medical Devices Regulation (see EUROPE 13501/9), the European Parliament calls on the European Commission to propose, by the end of the first quarter of 2025, delegated and implementing acts to this regulation and to the regulation on in vitro diagnostic medical devices, “in order to address the most pressing challenges and bottlenecks in the implementation of the legislative frameworks”.
The Commission is invited to propose that the systematic revision of all relevant articles of these regulations be carried out “as soon as possible”, accompanied by an impact assessment. An amendment tabled by the EPP calling for this revision to be conducted “by the end of the third quarter of 2025 at the latest” was rejected in plenary (277 votes in favour of Peter Liese’s amendment, 317 against and 47 abstentions).
By adopting an ECR Group amendment in plenary (310 votes in favour, 215 against and 80 abstentions), Parliament stressed the need to “protect health data collected by e-health applications”, by including these in the scope of the Medical Devices Regulation when it is revised, and by laying down appropriate provisions regarding these applications. (Original version in French by Lionel Changeur)