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Create initial PSR dossier

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

    vigilance-register-form.png

  2. Select the PSR template from the drop-down list:

    PSR_Step0.png

  3. Select the manufacturer from the Manufacturer field.

    The system will automatically display your Actor information.

  4. Enter the 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.