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Create initial PSUR dossier

  1. From the EUDAMED dashboard, click on Register a new Vigilance Form under the Vigilance section:

    EUDAMED VIG Register a new Vigilance form

    The system will redirect you to the Vigilance Templates screen.

  2. Select the PSUR template from the dropdown list:

    EUDAMED PSUR template dropdown

  3. Select the manufacturer from the appearing Manufacturer field:

    EUDAMED PSUR MF selection field

    The system will automatically retrieve your Actor ID/SRN.

  4. Provide the unique Manufacturer reference in the next field and click on Create Form, to complete this initial step:

    EUDAMED PSUR create form