Regulatory updateDevice regulation
EUDAMED: four modules are now mandatory
From 28 May 2026, mandatory use applies to actor registration, UDI/device registration, notified bodies and certificates, and market surveillance.
Why it matters
Useful context when evaluating European device documentation. Public data availability differs between modules and does not replace checking the device documentation.
Keep in mind
An implementation milestone, not a new device approval. The Commission announcement was published in November 2025.