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Create initial PSR dossier

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

    EUDAMED VIG register initial dossier link

  2. Select the PSR template from the dropdown list:

    EUDAMED VIG dossier template selection

  3. Select the manufacturer from the Manufacturer field.

    The system will automatically display your Actor information.

  4. Enter the unique Manufacturer reference.

  5. Click on Create Form to complete this initial step.

Important

The information provided in this step cannot be modified after you click Create form.