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EU's EUDAMED medical device database becomes mandatory

Rule Changes

Lobbying group representing device makers selling in Europe

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 Yesterday