Create initial MTR dossier
From the EUDAMED dashboard, click on Register a new Vigilance Form under the Vigilance section:
Select the MTR template from the drop-down list:
Select the manufacturer from the Manufacturer field. The system will automatically retrieve your Actor ID/SRN:
Enter the Manufacturer reference and select the Competent Authority from the drop-down list:
Click on Create Form to complete this initial step.
Important
The information provided in this step cannot be modified after you click Create form.