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Create initial MTR dossier

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

    vigilance-register-form.png

  2. Select the MTR template from the drop-down list:

    MTR_Step0_1.png

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

    MTR_Step0_2.png

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

    MTR_Step0_3.png

  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.