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Register new SS(C)P

  1. Click on Manage SS(C)P to navigate to SS(C)P management page from your dashboard:

    EUDAMED manage sscp link on the dashboard

  2. On the next page, click on Create new SS(C)P:

    EUDAMED create new sscp and fields to filter in the summary safety and clinical performance sscp management page

  3. Provide the certificate’s number, and its revision number if applicable, to identify the certificate registered before. Click Find:

    Note

    Only the following certificate types can be linked to new SS(C)P created within the SS(C)P management page:

    – (MDR/IVDR) EU Quality Management System certificate (Annex IX Chapter I)

    – (MDR) EU Quality Assurance certificate (Annex XI Part A)

    EUDAMED fields under the certificate identification and sscp information sections

  4. Once the certificate has been identified, its link will be populated in the box along with information about the manufacturer, and, if applicable, the authorised representative:

    EUDAMED details on the selected certificate in the create new sscp page

  5. Click the Remove Certificate information link if the certificate displayed is not the intended one. The process to identify the certificate will restart.

  6. Within Device(s) information, enter the Basic UDI-DI to be linked to this SS(C)P:

    EUDAMED basic udi-di code field and search button

  7. You may provide at least the first five characters of a Basic UDI-DI and click Search. The system will retrieve Basic UDI-DI(s) according to the Quality certificate types, risk class and their specific characteristics:

    EUDAMED list of basic udi-dis and close button

  8. Once a Basic UDI-DI is selected, the system will populate its details:

    EUDAMED details on the device and remove this device and add a device links

    You may add another Basic UDI-DI by clicking on the Add a device link, or remove this Basic UDI-DI by clicking on the Remove this device link.

  9. You need to specify SS(C)P reference and revision numbers, date issued and the language in which the SS(C)P master document is provided. Click Browse to upload the SS(C)P master document. Select Yes if this SS(C)P master document is validated, otherwise select No:

    EUDAMED is this sscp validated field and submit and cancel buttons

  10. Click Submit and Confirm when asked. A confirmation page will appear:

    EUDAMED confirmation message when submitting an sscp registration

    Your new SS(C)P record will appear under the list of SS(C)Ps within the SS(C)P management page.