EUDAMED Registration: Non-EU manufacturers blocked from EU market

Since 28 May 2026, EUDAMED registration and legal EU Authorized Representace became mandatory for non-EU manufacturers.

Manufacturers must now register as "actor" and appoint an local, EU-base Authorized Representative verfied by local Authorities, to be able to register medical devices and thus sell on the European market.

➡️ Notified Bodies must upload and maintain certificate information in EUDAMED.

➡️ Competent Authorities must enter summary reports of the results of their market surveillance activities across Member States.

Contact us and we handle the full mandate for you: EUDAMED registration, legal representation and Authirty communication in Germany.