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Restrict

To restrict a certificate, click on the three dots next to the desired certificate and then from the dropdown menu, click Restrict Certificate:

EUDAMED list with certificates and restrict certificate link under the three dots

On the next screen, you will find all information relevant to the specific certificate and a menu with different sections on the left.

  1. Complete the details for the default Certificate identification tab:

    EUDAMED certificate identification tab

  2. Scroll down and fill in the New Certificate Information:

    • The certificate number might change, if it is the case, enter the new Certificate number and a revision number. Alternatively, provide a Revision Number while keeping the same Certificate Number.

    • Select the date of expiry for this certificate and the starting date of validity of the restriction.

    EUDAMED certification number, revision number, date of issue, date of expiry, status and starting validity date fields

  3. Scroll further down to the section Status change reason and select the reasons for the certificate’s restriction (you can select more than one). In case you select Other, you must provide comments in all relevant languages of the specific certificate:

    EUDAMED status change reason and other reason fields

  4. Provide comments in all the languages of the certificate and click Save:

    EUDAMED comments field for all selected languages of the certificate and save, submit and cancel buttons

  5. Review all information under the Device(s) section, e.g. intended purpose, and where needed/possible, update or remove information accordingly:

    EUDAMED codes field in the devices section

  6. Fill in the intended purpose of the device in all the certificate’s languages and click Save:

    EUDAMED intended purpose field for all certificate's languages, remove this device link and save, submit and cancel buttons

  7. Review and update information under the Certificate details section in all relevant languages:

    EUDAMED conditions and limitations toggle to yes and conditions and limitations for all languages field

  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 per language or one document covering all languages:

    EUDAMED select the language of the certificate field and browse button

  9. Once you have successfully uploaded the new certificate document(s), click Save:

    EUDAMED 1 file uploaded successfully and save, submit and cancel buttons

  10. Click on the SS(C)Ps section from the menu on the left and click Create new version:

    EUDAMED create new version button in the sscps section

  11. On the next screen, complete all the steps to create a new version, i.e. provide SS(C)P revision number, issue date, upload SS(C)P document and click Confirm:

    EUDAMED fields in the create a new version of this sscp document screen

  12. Next, the system will display your newly created SS(C)P version for you to review. If you discover a mistake, you can click Discard and re-do the process, alternatively click Save:

    EUDAMED details on the sscp new version and discard, save, submit and cancel buttons

  13. When you have fully reviewed all the information provided, click Submit. The system will prompt you to confirm your submission. Click Yes to complete the process:

    EUDAMED confirmation window with yes and no buttons