EUDAMED Information Centre - PROD

Validating user access requests

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Registration requests from interested actors are displayed in the relevant competent authority's Tasks menu for validation. As a competent authority, you are expected to review incoming requests and decide whether or not to approve them.

To validate an actor registration request

  1. In the Tasks section of your dashboard, click Validate actor registration requests.

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    Figure 7 – Actor validation dashboard link

    Result: An overview of all actor registration requests pending validation is displayed:

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    Figure 8 – Pending actor registration requests

    Note

    Submitted vs. verified

    Registration requests in your pending requests list may have submitted or verified states.

    Submitted requests are from EU actors.

    Requests from non-EU manufacturers have to be verified by the actor's authorised representative before they become available for validation by the competent authority.

    Once verified, these requests appear in the competent authority's pending requests list as verified.

  2. From the Actions column in your ‘pending requests’ list, click Assess next to the actor you wish to validate.

    Result: All information entered by the actor is displayed:

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    Figure 9 – Actor registration form for validation

  3. Review the information and scroll down to the Assessment section. Here you can switch the toggle to either Approved or Not approved, enter any assessment comments in the Notes text box and then click Complete assessment.

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    Figure 10 – Actor registration assessment

  4. Confirm your decision whether or not to approve the request.

    Result: You are informed that the actor registration request has been successfully assessed:

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    Figure 11 – Actor registration assessment

If you approved the request, its state is now registered and an Actor ID or single registration number (SRN) is generated for the actor.

The Local Actor Administrator who submitted the request is informed of this by email.

Note

In the event of non-approval:

If you decide not to approve the request, you must select the reason why and provide a justification:

Incomplete or incorrect, wrong competent authority and/or authorised representative and duplicate: will remove the request from the pending requests list and return it to the requester with a state of Correction requested. The Local Actor Administrator will be informed by email. The requester should then follow the instructions that you entered in the justification box, update and re‑submit the request.

Request no applicable: will move the request from the pending requests to the refused requests tab with Refused state. The Local Actor Administrator will be informed by email. The requester can view your justification, but the request cannot be re-submitted.

Fraud suspected: will move the request from the pending requests to the refused requests tab with fraud suspected as the reason for refusal. The Local Actor Administrator will be informed by email. The requester cannot view the justification that you provided and the request cannot be re-submitted.