Olivér Várhelyi

European Commissioner for Health and Animal Welfare

Appears in 1 story

Stories

EU's EUDAMED medical device database becomes mandatory

As of May 2026: Oversees DG SANTE, which signed off on the audit triggering mandatory use

Until today, registering a pacemaker, hip implant, or COVID test for sale in Europe meant filing paperwork with each of the 27 national regulators. From May 28, 2026, there is one database. Every medical device and in vitro diagnostic sold in the EU must be entered into EUDAMED, the centralized European registry, before it reaches a hospital shelf.

Updated May 28