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Provide comments to FSNs

CAs responsible for Vigilance that are associated to the countries selected in the FSN can provide comments to a preliminary FSN.

Submit comments as a CA

  1. Access the relevant FSN via Search & View Vigilance items.

  2. Click on Provide comments at the top right corner of the screen:

    EUDAMED Report primary details screen with Provide comments button

  3. Provide your comments in the pop-up text box and click on Complete action:

    EUDAMED pop-up window with Comments text field, Complete action button and alternative Close button

    Note

    Clicking Close will cancel the process; the comments typed will be lost, and you will be redirected to the previous screen.

View and follow-up CA comments

After comments have been successfully submitted by the CA, the FSN will contain a new CA comments tab which can be viewed by the MF/AR, the referenced NBs and all CAs with permissions for Vigilance.

Important

Upon submission of CA comments, all actors referenced in the FSN and in the linked FSCA(s) will receive an information notification:

EUDAMED Information notification example for all involved actors

If no comments have been provided by the CAs within two working days after the preliminary FSN submission, the MF/AR will receive an action notification:

EUDAMED Action notification example for MF/AR

Having accessed the relevant FSN via Search & View Vigilance items, click on the CA comments tab on the left to see the comments:

EUDAMED CA comments tab on the tab menu

Tip

CA comment entries can also be viewed under the Action history overview tab, inside the relevant historical version.