Skip to main content

4-Years MS Review Report

EUDAMED manage all reports link on the dashboard

  1. Click Manage all reports, click Create new report and select the 4-Years MS Review Report option.

    EUDAMED 4-years ms review report link under the create new report button

  2. Provide a unique local CA reference and select the applicable regulation(s). (If you select both, you should provide a single report covering both):

    EUDAMED ca reference for this four years report and applicable regulations fields

  3. Input the review period start date (year and month). The values depend on the application legislation as selected. For example, MDR selected alone would start from May 2021, while IVDR would start from 2022. Both selected would offer the May 2021 start-date possibility.

    EUDAMED period start and period end fields

  4. The Period end year appears in the report identifier.

  5. Two different files are to be uploaded: one 4-Years Results Report file, and one 4-Years Summary Report file.

    Click Submit:

    EUDAMED abstract summary text, four years results report file link and browse button
    EUDAMED submit and cancel buttons

    Note

    There is no report draft. The record will be directly submitted.

  6. Click Confirm, and the confirmation screen displays the successful registration of the 4-year review (i.e. the results and summary combination):

    EUDAMED confirmation popup window with confirm and cancel buttons
    EUDAMED confirmation message after submitting a 4-years ms review report registration

    A notification is sent to all related users.