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Merge certificates when re-issuing a Quality certificate

  1. Click on the three dots next to the desired certificate, then click Re-issue Certificate:

    EUDAMED re-issue certificate link under the three dots

  2. On the next screen, click + Add another preceding certificate:

    EUDAMED add another preceding certificate link

  3. Type the new preceding certificate number and optional revision number then click Find:

    EUDAMED preceding certificate number and preceding certificate revision number, find button and remove this preceding certificate link

  4. When there is more than one certificate with the same reference number and no revision number is provided, the system will display a selection dialog:

    EUDAMED list with certificates in the find a certificate pop-up window and close button

  5. The new preceding certificate information will appear on the list. You have the option of removing it:

    EUDAMED preceding certificate information page

  6. Next, fill in the New Certificate Information and click Save & Next:

    EUDAMED certificate number, revision number, date of issue, date of expiry and starting validity date fields and save and next and cancel buttons

  7. The next screen will display a timeline of steps. Follow the order, starting from the first section Certificate languages.

    Click Add more languages if necessary and click Save & Next to complete this step:

    EUDAMED list with all selected languages, add more languages link and save, save and next and cancel buttons

  8. In the next step – Device group(s) – EUDAMED will populate the device groups from the preceding certificate(s), if any. Verify the merged certificate and fill in any required information:

    EUDAMED identification of the device group and risk class fields

  9. To proceed to the next step, click Save & Next:

    EUDAMED list with clickable device groups, add a device group and save, save and next and cancel buttons

As the remaining actions to complete the process are identical to re-issuing a Quality certificate, please consult steps 11-20 of Re-issuing a Quality/Product certificate.