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Amend

  1. To amend a certificate, repeat steps from Update a certificate, click the three dots under Actions and click Amend Certificate:

    EUDAMED amend certificate link under the three dots button
  2. You will arrive to the following page:

    EUDAMED certificate identification section
  3. To select another version of the Manufacturer, Producer or Authorised representative, click on Update with new actor version link.

    You will see a dialog to select another version of this actor (if one exists):

    EUDAMED select the new actor version in the list and select this version button
  4. Click the Select this version button to select the actor version and close this dialog.

    The Preceding certificate information box displays core information about the preceding certificate:

    EUDAMED preceding certificate information section
  5. Below that, you will see the following:

    EUDAMED new certificate information fields
  6. The certificate number might change, if it is the case, enter the new Certificate Number and add a revision number. Enter the date of issue and the starting validity date.

    Select one of the reasons for the change to the certificate and add a comment in the language in which the certificate was registered:

    EUDAMED status change reason and comment fields
  7. In the next steps, you will have to enter the information as if you were creating a new certificate:

    EUDAMED certificate identification section
  8. To provide the new Certificate document, tick the relevant languages and click Browse to upload the document(s) from your computer. You can upload either one document containing one/some language(s) or one document covering all languages:

    EUDAMED select the language of the certificate field and browse button
  9. Once complete, click either Save to save your work without submitting, or Submit:

    EUDAMED save, submit and cancel buttons