Create initial FSCA dossier
From the EUDAMED dashboard, click on Register a new Vigilance Form under the Vigilance section:
The system will redirect you to the Vigilance Templates screen.
Select the FSCA report template from the drop-down list:
Select the manufacturer from the Manufacturer field:
The system will automatically retrieve your Actor ID/SRN.
Provide the FSCA Manufacturer reference in the next field as well as the country of the coordinating Competent Authority:
Depending on the country selected, you might have to choose a specific Competent Authority among several:
Click on Create Form to complete the creation of the FSCA: