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EUDAMED Registration Becomes Mandatory – May 2026

May 28 All day

Regulatory Alert | EUDAMED becomes mandatory

Commission Decision (EU) 2025/2371 confirms the full functionality of the first four EUDAMED modules. As a result, economic operators must comply with mandatory registration requirements.

Mandatory modules from 28 May 2026:

Market Surveillance

Actors: registration of manufacturers, authorised representatives, importers

UDI / Devices: device registration (excluding custom-made devices)

Notified Bodies & Certificates

A six-month transition period (until November 27, 2026) applies only to devices placed on the market before May 28, 2026. Devices placed on the market after this date must be registered before market access.

Obelis supports manufacturers at every step of EUDAMED compliance!