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Re-issuing a Quality/Product certificate

  1. To re-issue a certificate, for example due to its imminent expiry, click on the Certificates management page then filter to identify the certificate you want to re-issue:

    EUDAMED manage your certificates link on the dashboard and certificates management page

    Warning

    Notified Bodies may have up to three months between expiry date of previous certificate and the issued date and starting validity date of re-issued certificate.

  2. Select Registered as the state. From the list generated, in the Actions menu click the three dots next to the intended issued certificate and select Re-issue Certificate:

    EUDAMED registered state selected and re-issue certificate link under the three dots

  3. The next screen will display all relevant information of the certificate. If necessary, click Update with new actor version:

    EUDAMED information of the certificate and update with new actor version in the re-issued certificate registration page

  4. Select the right actor version from the list:

    EUDAMED list with versions of the selected actor and select this version and cancel buttons

  5. Scroll down to the New Certificate Information section. Duplicate the certificate identifier, and note the duplication warning message. Add a Revision number so it differs from the preceding certificate – the warning disappears. Select the new issue date, validity date and expiry date (noting the maximum period is five years). Now click on Save & Next to proceed:

    EUDAMED fields in the new certificate information section and save and next and cancel buttons

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

  6. Click on Add more languages if necessary:

    EUDAMED add more languages link and save, save and next and cancel buttons

  7. On the pop-up window, click on the desired languages and press Select:

    EUDAMED pop-up window with languages and select and cancel buttons

  8. Click Save & Next to proceed to the next section:

    EUDAMED selected languages and add more languages link in the certificate languages step and save, save and next and cancel buttons

  9. Fill in the information required to complete the Device group(s) step, when a certificate is re-issued, no change can be made.

    EUDAMED identification of the device group and risk class fields

  10. Click + Add a device group and then again on the appearing Device group item:

    EUDAMED remove this device group and add a device group links and save, save and next and cancel buttons
    EUDAMED clickable device group, remove this device group and add a device group links and save, save and next and cancel buttons

  11. Fill in the required information and click Save & Next:

    EUDAMED identification of the device group and risk class fields, remove this device group and add a device group links and save, save and next and cancel buttons

  12. Fill in the information for the Device(s) step:

    EUDAMED fields in the devices step

  13. Click + Add a device group and then click on the Item that displays under Device(s):

    EUDAMED clickable device and item, add a device group link and save, save and next and cancel buttons

  14. Add the required information to complete this step and then click Save & Next:

    EUDAMED custom made class III implantable and description fields, remove this device and add a device links and save, save and next and cancel buttons

  15. Fill in the information required to complete the Certificate details step:

    EUDAMED special device type within the scope field

  16. Provide comments regarding Conditions and Limitations in each language you selected:

    EUDAMED conditions and limitations field

  17. To provide the new re-issued 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

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

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

    At this point, depending on the specifics of the certificate, the system may take you to the next step called SS(C)Ps. If not relevant for the specific certificate, this step will be omitted. You have three possibilities when adding new devices.

    blob.png Add device(s) to an existing SS(C)P from the preceding certificate (see Step 19).

    blob.png Add device(s) to a new version of the SS(C)P from the preceding certificate (see Step 20).

    blob.png Add device(s) to a newly registered SS(C)P (see Step 21).

  19. Add device(s) to an existing SS(C)P from the preceding certificate.

    Click on Add SS(C)P. The existing devices show, but are inactive. Select any new device(s) and click Confirm:

    EUDAMED add a new device to this sscp link and fields in the add a basic udi-di pop-up window

    Note

    If you have referenced a Basic UDI-DI in Submitted state, then upon submitting your certificate, you will be asked to confirm the accuracy of the device data registered for the referenced Basic UDI-DI:

    confirm_the_accuracy_of_the_device.png

    After the certificate is submitted, the state of the Basic UDI-DI will be updated to Registered. The Basic UDI-DI(s) and their related UDI-DI(s) will then become visible on the EUDAMED public site.

    The new device appears next to the dustbin icon. If you save now, the new device will be linked to this version of the SS(C)P:

    EUDAMED dustbin icon next to the device and add a new device to this sscp link

  20. Add devices to a new version of the SS(C)P from the preceding certificate. With this approach, click Create new version:

    EUDAMED create new version button

    Input the SS(C)P reference number, and create a revision number, then specify the issue date:

    EUDAMED sscp reference number, sscp revision number and issue date fields and delete this draft and browse buttons

    Click Browse to locate and upload the master document, and click to confirm it is validated:

    EUDAMED browse button and checkbox to confirm the validated version

    Click + Add a new device to this SS(C)P, locate and select the new device, and click Confirm to link it to this new SS(C)P version:

    EUDAMED add a new device to this sscp and fields in the add a basic udi-di pop-up window

    Note

    If you have referenced a Basic UDI-DI in Submitted state, then upon submitting your certificate, you will be asked to confirm the accuracy of the device data registered for the referenced Basic UDI-DI:

    confirm_the_accuracy_of_the_device.png

    After the certificate is submitted, the state of the Basic UDI-DI will be updated to Registered. The Basic UDI-DI(s) and their related UDI-DI(s) will then become visible on the EUDAMED public site.

    Click Save, and when you register the certificate, this SS(C)P will be saved:

    EUDAMED save button and details in the sscps page

  21. Registering a new SS(C)P, then adding device(s) to it. Click + Add SSCP, then provide the reference and revision number:

    EUDAMED add sscp link and sscp reference number and sscp revision number fields, check registry button and remove this sscp and metadata

    Click Check registry. The system will confirm this is a new SS(C)P:

    EUDAMED system message

    Complete the fields for the new SS(C)P, including the master document language. Click Browse to locate and upload the master document, confirming it is validated (for Quality-type certificates):

    EUDAMED browse button and is this sscp validated field

    Scroll to the bottom and click + Add a new device to this SS(C)P, then select the device(s). Click Confirm and Save:

    EUDAMED add a new device to this sscp link and pop-up window with a list with basic udi-di codes and confirm and cancel buttons

    At this point, if a high risk device, as defined in Article 55 (MDR) and Article 50 (IVDR), was referenced, the system will take you to the next step called Mechanism for scrutiny.

  22. If the certificate you are reissuing is associated with an IVDR high risk device, the fields appearing in the Mechanism for scrutiny step will be the same as in the Case B of the Provision of Mechanism for scrutiny page. Otherwise, if the certificate you are reissuing is associated with an MDR high risk device, follow the steps listed below.

    Case A: CECP records found in the system

    Follow the steps described in the Case A of the Provision of Mechanism for scrutiny page.

    Case B: No CECP records found in the system

    Select Yes or No in the field Was CECP followed?:

    EUDAMED was cecp followed field in the mechanism for scrutiny stem when supplementing a certificate

    If you select Yes, the Mechanism for scrutiny done outside EUDAMED? field appears and you must set the toggle button to Yes to indicate that the Mechanism for scrutiny was done outside EUDAMED. Otherwise, the system will prevent you from continuing, unless you have selected No in the Was CECP followed? field.

    Note

    It is also possible to scrutinise again a device for which the initial Mechanism for scrutiny has been finalised. If a new CECP record has been registered for the Basic UDI-DI then, during the certificate reissue process, the Mechanism for scrutiny step will be provided.

  23. After having reviewed all information, click Submit:

    EUDAMED save, preview, submit and cancel buttons

    The system will prompt you to confirm your submission of a re-issued certificate.

  24. Click Submit my request to finalise the process:

    EUDAMED confirmation pop-up window with submit my request and cancel buttons

  25. The system will confirm your submission has been successful. You can also view the newly created certificate by clicking on the link provided:

    EUDAMED confirmation message when submitting a certificate registration

Merging two or more certificates when re-issuing a Quality certificate