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Create initial NCAR dossier

  1. On the EUDAMED dashboard, click on Register a new NCAR under the Vigilance tab:

    EUDAMED Vigilance tab

    The system will redirect you to the Vigilance Templates screen.

  2. Select the NCAR template from the dropdown:

    EUDAMED Drop-down list for selection of a Vigilance template

  3. Select the country of Competent Authority and the specific Competent Authority and click Create Form, to complete this initial step:

    EUDAMED Drop-down list for selection of Country of Competent Authority and Create Form button