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Case C: 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:

    NCAR_Vig_Related_2.png

    If you answered Yes, you have to select the Actor ID/ SRN from the drop-down that will appear and, if applicable, fill in the Authorised Representative fields:

    NCAR_Vig_Related_3.png

  3. Provide reference to any related Vigilance items, registered or not registered in EUDAMED:

    EUDAMED Vigilance item information section

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

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

  5. Click on Browse under Related documents to attach any documents relevant to the information provided:

    EUDAMED NCAR Attach documents button

  6. Tick the impacted country(/-ies), the Competent Authorities of which will be notified about this NCAR:

    EUDAMED NCAR Impacted countries

  7. Submission:

    Click Submit on the top right corner:

    EUDAMED Submit button

  8. Finalise the submission of the report by clicking 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