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Final Inspection Report

EUDAMED a final inspection report link on the dashboard

  1. Click Create new report and select the FIR.

    EUDAMED final inspection report link under the create new report button in the reports management page

  2. Enter the CA reference number and select the applicable regulation(s):

    EUDAMED ca reference for this final inspection report and applicable legislation fields

  3. Identify the Economic Operator(s) inspected. Click I know the Actor ID/SRN to input the data or partial data, then click Find to select the EO:

    EUDAMED actor id/srn field and find button with popup window with list of economic operators

  4. You may select multiple EOs. Click Add another EO. You can also search by Role or Organisation name, then click Check registry:

    EUDAMED add another eo link and fields to complete in the economic operation information section

  5. If the EO does not appear in the selection results, you can Enter data manually (manually entered EO are saved as separate entity with no links to Actors):

    EUDAMED enter data manually button and fields related to the economic operator to complete

  6. Remember to click Save at the bottom of the page. A message confirms the data is saved, so you can return to this later:

    EUDAMED save, submit and cancel buttons

  7. You may add one (or multiple) NBs, which will receive a notification of the report. They are now referenced in the procedure, and therefore they have access to related procedure items/objects:

    EUDAMED select a notified body field

  8. Finally, upload one PDF-format report. Click Submit:

    EUDAMED final inspection report type field and browse, save, submit and cancel buttons

  9. Confirm that you want to register this FIR report. The confirmation page displays, which links back to the Dashboard or the Manage all reports page:

    EUDAMED confirmation popup window with confirm and cancel buttons
    EUDAMED confirmation message when submitting a final inspection report registration