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Create new version of a registered SS(C)P

You can reference an existing SS(C)P that is already registered, and link other devices to it. However, you can also create a new SS(C)P version, while referencing an existing SS(C)P.

  1. Click Create new version:

    EUDAMED create new version button

  2. The warning message requests a revision number that must be different from the previous version, a manufacturer-provided issue date and a new master document. Click Date issued and input the date:

    EUDAMED fields and warning message in the sscp information section

  3. Click Browse to upload the new master document in the pre-selected language, and confirm that it has been validated where applicable (SS(C)P on devices that only need a quality certificate may not necessarily be validated already):

    EUDAMED popup window when selecting the browse button

  4. The Device(s) information box confirms no associated devices. Click Add a new device to this SC(C)P. The pop-up shows two sections: the Basic UDI-DI(s) referenced in this certificate of class IIa implantable and relevant class IIb implantable or relevant class C, and (for Quality certificates only) a list of all Basic UDI-DIs of class IIa implantable and relevant class IIb implantable or relevant class C registered by the referenced manufacturer. You can select multiple devices:

    EUDAMED fields in the add a basic udi-di page when selecting the add a new device to this sscp link

  5. You can input a partial Basic UDI-DI number and click Filter to narrow down the search results:

    EUDAMED basic udi-di code field and filter button

  6. Once selected, click Confirm to link the devices to the SC(C)P new version. Nothing is yet submitted, and you can delete the inputs/links by clicking Delete this draft to return to the previous screen:

    EUDAMED delete this draft button

  7. You may also perform the tasks in reverse order. First select the Basic UDI-DI(s), then click Create new version and input the revision number, date and master document etc.:

    EUDAMED create new version button and sscp revision number field

  8. Click Save to continue, or Submit. In the confirmation click Submit my request:

    EUDAMED submit my request and cancel buttons

  9. From the confirmation page, click View the certificate you just created:

    EUDAMED confirmation message when submitting a certificate registration and view the certificate you just created link

  10. You can view the newly created certificate version, and all the devices linked to the new registered SS(C)P version:

    EUDAMED details on the sscp tab