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Provision of core data

  1. Enter the core information for the refused certificate:

    EUDAMED fields for the provision of core data of the refused certificate

  2. Select the applicable Regulation and the conformity assessment procedure. Then enter the application reference.

    Note

    In this scenario we will choose a Product certificate type.

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

  4. Manufacturer identification

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

    EUDAMED manufacturer identification details and save and next button

  5. Click Save & next.