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Create initial FSCA dossier

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

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    The system will redirect you to the Vigilance Templates screen.

  2. Select the FSCA report template from the drop-down list:

    fsca-template.png

  3. Select the manufacturer from the Manufacturer field:

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    The system will automatically retrieve your Actor ID/SRN.

  4. Provide the FSCA Manufacturer reference in the next field as well as the country of the coordinating Competent Authority:

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  5. Depending on the country selected, you might have to choose a specific Competent Authority among several:

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  6. Click on Create Form to complete the creation of the FSCA:

    FSCA_Step0_6.png