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Provision of SS(C)P documents

For certain high-risk devices that are implantable, the provision of an SS(C)P applies.

  1. An SS(C)P record within EUDAMED can be attached to many certificates. Hence, the initial dialog requires the provision of an SS(C)P reference number and SS(C)P revision number. Once provided, click Check registry:

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

  2. If the record exists in EUDAMED, it will be displayed. Otherwise, you may enter a new SS(C)P registration. Enter the issued date and select the language of the document. Click Browse to upload the SS(C)P master document:

    EUDAMED date issued and select the document language fields and browse button

  3. The Device(s) information box confirms no associated devices. Click Add a new device to this SC(C)P. The pop-up shows the Basic UDI-DI(s) referenced in this certificate. You can select multiple devices to associate to this SS(C)P:

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

    Once selected, click Confirm to link the devices to the SC(C)P. Nothing is yet submitted, and you can remove this SS(C)P by clicking on Remove this SS(C)P and metadata and return to the previous screen.

    You may register more than one SS(C)P. Select the device that is described by the SS(C)P being registered and click Confirm.

  4. To register additional SS(C)Ps, click on Add SSCP. You will be provided with a new SS(C)P search dialog:

    EUDAMED fields when registering additional sscps

  5. When registering additional SS(C)Ps, by clicking on Add a new device to this SS(C)P the system will display the remaining devices in the scope of the certificate to be linked to the additional SS(C)P:

    EUDAMED add a basic udi-di window when clicking add a new device to this sscp link
    EUDAMED fields to be filled in when registering additional sscp

  6. When finished, click Save or Save & Next.

  7. Alternatively, you can create a new version of an existing SS(C)P. Click Create new version and provide a version number, issue date and master document (see Provision of SS(C)P documents for Quality certificates). Click Add a new device to this SS(C)P to add new devices to this new SS(C)P version:

    EUDAMED create new version button and add a new device to this sscp link

  8. The pop-up lists Basic UDI-DI(s) which are referenced in the certificate. No others can be added. Select one or multiple from the display, and click Confirm:

    EUDAMED basic udi-di referenced in this certificate field and confirm and cancel buttons

    The selected devices are listed:

    EUDAMED devices information, create new version button and add a new device to this sscp and remove this sscp and metadata links

  9. You can still create a new version using the Create new version button as shown previously, and the selected devices will link to it. Click Save & Next to proceed:

    EUDAMED save, save and next and cancel buttons

  10. Click Save or Save & Next.

  11. Confirm your submission by clicking on Submit my request in the pop-up window:

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

    You will be shown a page confirming your registration:

    EUDAMED confirmation message when submitting a certificate registration

    From here you can click View the certificate you just created to view the certificate, or you can click the Go to homepage.