Create initial MIR dossier
From the EUDAMED dashboard, click on Register a new Vigilance Form under the Vigilance section:
Important
Please remember that the information that you provide in this step cannot be modified after you click Create form.
Select MIR from the drop-down list:
Insert the manufacturer Actor ID/ SRN in the Manufacturer field appearing below. The system will automatically retrieve your Actor ID/ SRN:
Provide the Manufacturer’s reference number for this incident (provided by the manufacturer) and select the country in which the incident took place from the Country drop-down list:
Select the correct Competent Authority from the dropdown list. The system will automatically retrieve the relevant CA:
Click on Create Form at the bottom of the screen: