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Corrective actions

  1. The Unacceptable risk procedure data reference displays. A corrective action is mandatory to be able to submit the procedure. Click the Corrective actions tab. The corrective actions identifier displays, containing the procedure reference, and the abbreviation 'COA' followed by a reference number:

    EUDAMED corrective actions tab
    EUDAMED corrective actions identifier

  2. Provide a corrective action reference number, and define the corrective action type:

    EUDAMED local ca corrective action reference and corrective action type fields
    EUDAMED dropdown options of the corrective action type field

    1. You can specify multiple types. If you select Other, enter an explanation:

      EUDAMED corrective action comments field

  3. Indicate if the procedure is related to Vigilance report(s) and enter the reference(s):

    EUDAMED this procedure is related to vigilance reports and enter vigilance report reference fields
    EUDAMED this procedure is related to vigilance reports and enter vigilance report reference fields and check registry button

  4. Provide a justification for the corrective action, and clicking Browse you can upload one or multiple supporting files:

    EUDAMED justification field and justification file fields, browse button and link to the uploaded document

  5. The affected country is already set, i.e. the country of the initiating CA. You can select other affected countries:

    EUDAMED add another country link and pop-up window with countries

    1. The countries can be removed, however the initial actor country cannot, i.e. the Belgian CA:

      EUDAMED affected countries field

  6. Provide the date of the entry into force of the corrective action –⁠ this may be in the past, present or future, i.e. in the case that the action has already been carried out. The Corrective action performed data/status date is not mandatory:

    EUDAMED date of entry into force, corrective action performed date/status date and corrective action status fields

  7. Click Add corrective action to add additional corrective actions in the same way. A sequential identifier will be generated:

    EUDAMED corrective action identifier

  8. Submit the procedure with the corrective action(s). Click Yes that you understand the disclaimer:

    EUDAMED save, submit and cancel buttons and msu procedure submission popup window with yes and no buttons

    1. The Commission, all CAs with market surveillance responsibility, and any NBs referenced in the procedure are notified:

      EUDAMED confirmation message after submitting an msu procedure registration

Once the unacceptable risk procedure has been submitted, the initiating CA can add measures to the procedure. Moreover, other CAs can submit an objection to the measure(s) submitted by the initiating CA, and they can also register their own measures. For these items, new versions can be created and submitted.

Important

Remember to click Save during the completion of each step. There is no autosave function, and unsaved inputs will be lost if you log out or otherwise lose connection to EUDAMED.