Skip to main content

Create initial PSUR dossier

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

    image160.png

    The system will redirect you to the Vigilance Templates screen.

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

    psur-template.png

  3. Select the manufacturer from the appearing Manufacturer field:

    image162.png

    The system will automatically retrieve your Actor ID/SRN.

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

    image163.png