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Case D: Vigilance items-related NCAR

  1. Select the Vigilance items related NCAR category in the first field of the NCAR Registration section:

    EUDAMED NCAR category drop-down with Vigilance items related NCAR selected

  2. Select Yes or No in the Manufacturer field, as shown below:

    EUDAMED Yes or No question: Is the MF registered in EUDAMED?

  3. Specify if the Manufacturer has an Authorised Representative:

    EUDAMED Yes or No question: Is an AR applicable?

  4. Provide reference to a Vigilance report:

    EUDAMED Vigilance item information section: Form type drop-down and Vigilance item reference from EUDAMED drop-down.
    EUDAMED Form type selection example

  5. Provide any useful and relevant comments in the description fields under Additional information:

    EUDAMED Additional information fields: Comments, Background information, Conclusions, Recommendations

  6. Submission:

    Submit the report by clicking on the blue Submit button on the top right corner:

    EUDAMED Submit button

  7. Finalise the submission of the report by clicking on Complete action in the pop-up window:

    EUDAMED Submission pop-up window with Complete action button and alternative Close button

Note

CAs with LAA profile only that were selected in the report, after submitting or updating the version of a NCAR form, will receive a notification in their Notifications inbox (Information tab):

EUDAMED Notifications inbox with received notification example