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Provision of core data

  1. Select the applicable regulation, and the certificate type. The type of the certificate will change depending on the regulation, MDR or IVDR.

    Note

    In this scenario we will choose a Quality certificate type.

  2. Select Yes or No whether the certificate is for a system or procedure pack.

  3. Enter the Certificate Number and a Revision number if applicable.

  4. Enter the Date of issue, the Starting certificate validity date and the date of expiry:

    EUDAMED fields in the certificate core information page

    Note

    Manufacturer information

    Enter the Actor ID/SRN or name of the manufacturer or the system/procedure pack producer, click Find and select from the list displayed.

  5. Click Save & Next.