ESC welcomes EU plan to revise Medical Device Regulation

The European Society of Cardiology welcomed the European Commission's confirmation, on 29 April 2026, that it will bring forward a targeted revision of the EU Medical Device Regulation. The Society called the move a long-overdue response to availability concerns affecting cardiology devices in the EU market.

The Society had repeatedly flagged that the current regulation, in force since 2021, has resulted in delays to recertification of established cardiac devices and to first-in-EU launches of new ones. ESC President Thomas Lüscher said the revision must restore predictability for clinicians and patients while keeping post-market surveillance at the heart of the regime.

ESC said it would work with sister societies, including the European Heart Rhythm Association, the European Association of Percutaneous Cardiovascular Interventions, and MedTech Europe to shape the revised text.