Skip to main content

Unacceptable risk procedure

  1. Select Unacceptable risk procedure from the dashboard, click Next, and EUDAMED generates a procedure identifier with the abbreviation 'UNR', the country, year and reference. Note the Corrective action button already appears, because it is a mandatory requirement of this procedure type and cannot be added after submission:

    EUDAMED choose a procedure type field and next and cancel buttons in the msu procedure registration page
    EUDAMED procedure information page

  2. Enter the Local CA procedure reference.

  3. Select at least one Procedure trigger and provide the Procedure trigger CA link (see the tooltip for details):

    EUDAMED fields in the procedure trigger information section and check registry button

    For other trigger types, except for ‘Other’, the user may provide a Procedure trigger CA reference not mentioned in the text:

  4. If you select Other, provide the description:

    EUDAMED procedure trigger, description and procedure trigger files fields and browse button in the procedure trigger information section

    You may upload several Procedure trigger files (PDF format, max 10MB each):

    EUDAMED browse button and link to the pdf file and remove this procedure trigger link

  5. You can register multiple triggers in the same way via the Add procedure trigger button:

    EUDAMED procedure trigger field

The Procedure status is set to Open in the initial version of the procedure. The field becomes editable only in a new version:

EUDAMED procedure status and procedure comments fields

Trigger - Incident

Trigger - FSCA

Trigger - FIR

Economic operator information

Device information

Corrective actions