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Independent resource centre

What EUDAMED steps apply to a non-EU manufacturer?

To request actor registration, a non-EU manufacturer needs an active authorised representative and must provide a mandate summary with the request.

Independent resource, not affiliated with the European Commission. If in doubt, official documentation and your competent authority prevail.

Let's EUDAMED

Points to check

  1. 01

    Check that the authorised representative is correctly registered and active in EUDAMED.

  2. 02

    Prepare the mandate summary required for actor registration.

  3. 03

    Submit the actor request in the official portal and await the competent authority's review.

  4. 04

    Then organise user access and device-data preparation for the applicable scope.

Official sourceCommission européenne — EUDAMED

Let's EUDAMED

What Let's EUDAMED does — and does not do

Let's EUDAMED helps prepare, check and transform data into XML files. Registration, SRN issuance and submission remain within EUDAMED or with the competent authority. EUDAMED credentials must never be shared with us.

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