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Create initial MIR dossier

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

    EUDAMED dashboard Vigilance tab
    EUDAMED Register a new Vigilance form link
    EUDAMED Vigilance template drop-down

    Important

    Please remember that the information that you provide in this step cannot be modified after you click Create form.

  2. Select MIR from the drop-down list:

    EUDAMED Vigilance template with MIR selected

  3. Insert the manufacturer Actor ID/ SRN in the Manufacturer field appearing below. The system will automatically retrieve your Actor ID/ SRN:

    EUDAMED Manufacturer type-in field

  4. 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:

    EUDAMED Manufacturer reference number type-in field and Country drop-down list

  5. Select the correct Competent Authority from the dropdown list. The system will automatically retrieve the relevant CA:

    EUDAMED Competent Authority drop-down list

  6. Click on Create Form at the bottom of the screen:

    EUDAMED Vigilance template filled and Create Form button