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Provision of core data

  1. Enter the core information for the refused certificate.

  2. Select the applicable Regulation and the conformity assessment procedure.

    Note

    In this scenario we will choose a Quality certificate type.

  3. Indicated Yes or No for a System Procedure Pack, then, enter the application reference number.

  4. Provide the dates for both the application submission and the date of issue of the refusal:

    EUDAMED fields in the provision of core data section

  5. Manufacturer information

    Enter the Actor ID/SRN or name of the manufacturer or the system/procedure pack producer, then select the appropriate on from the displayed list:

    EUDAMED list with the manufacturers and save and next button

  6. Click Save & next.