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Validating Economic Operator access requests

[Section for Local User Administrators]

Anyone with an EU Login account can request access to a registered Actor, but only a user with a Local User Administrator (LUA) or a Local Actor Administrator (LAA) profile can validate these requests. The person who registers an actor in EUDAMED automatically receives an LAA profile for this Actor. This includes the LUA rights for managing new user access requests.

As an LAA or LUA for the actor, you will be notified of all new or updated incoming access requests.

Users cannot access EUDAMED until their access request is approved.

To validate an access request

  1. Log in to EUDAMED.

  2. From your dashboard, select Assess user access requests (in the User management section):

    EUDAMED assess user access requests link in user management page

    The Pending requests tab on the Users management page lists all pending user access requests for your Actor:

    EUDAMED pending user access requests in users management page

  3. Click EUDAMED list icon Assess access request in the Actions column to view and assess a request from the list. Part 1. of the access request is displayed:

    EUDAMED assess access request for Economic Operators

  4. Review the information in Part 1. of the request.

  5. In the Assessment section, slide the toggle left to Approve the request, or right to Reject.

    • If you select Approve, the Next step button remains available at the bottom of the page (go to Step 6).

    • If you select Reject, you must add a comment and select one of the following reasons:

    Incomplete and/or details to correct:

    Some information is either missing or looks incorrect. The requesting user will have a chance to correct or complete the request following your instructions and re-submit the request.

    Refused request:

    The request will be refused, and the requesting user is not invited to re-submit.

    EUDAMED reject access registration request toggle button, types of reasons and remarks fields when validating Economic Operator access requests

    This ends the steps you need to follow to reject a request (ignore steps 6-8 below). The rejected request is listed in the Refused requests/users tab:

    EUDAMED refused requests/users tab in the user management page

  6. If you decided to approve, click Next step.

    EUDAMED next step button when validating Economic Operator access requests

    A table is shown with the user profiles for all available modules. The Viewer profile is automatically granted to each user:

    EUDAMED requested profiles when validating Economic Operator access requests

    Note

    Profile availability

    The profiles available in the table depend on the actor role – e.g. if the user is requesting access for an authorised representative, the additional profile of Verifier will be available.

  7. For each module in the table, click either Accept or Reject, and when you are done, click Complete assessment.

    A summary is displayed of the user profile you have approved.

  8. To confirm this user profile, click Confirm in the summary dialog box.

    You are informed that the access request has been properly assessed:

    • The status of the request will update to validated.

    • The user details are moved to the Registered users tab, on the Users management page.

    • The user is notified that their access request has been validated.