Skip to main content

Create initial MTR dossier

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

    EUDAMED VIG Register new form

  2. Select the MTR template from the dropdown list:

    EUDAMED VIG form template selection

  3. Select the manufacturer from the Manufacturer field. The system will automatically retrieve your Actor ID/SRN:

    EUDAMED VIG template MTR MF selection

  4. Enter the unique Manufacturer reference and select the Competent Authority from the drop-down list:

    EUDAMED MTR MF 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.