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Measure(s) linked to UNR procedures

After first submission of the unacceptable risk procedure, the initiating CA can add one or several measures. This is only possible when the corrective action(s) has not been implemented by the EO within the specified time-period, and the procedure is therefore still 'open'. Measures cannot be added to a closed procedure.

  1. Click Measures by initiating CA & objections:

    EUDAMED measures by initiating ca and objections link
  2. A list of possible measures will appear. Select from this or click Add new measure. The input screen is the same for measures for all three procedure types:

    EUDAMED add new measures button in the measures by initiating ca and objections tab
    EUDAMED fields after clicking the add new measures button
  3. Enter the Local CA measure reference. Select the Measure type. The Other option requires more information:

    EUDAMED measure type field
  4. Provide a justification and upload one or multiple supporting files:

    EUDAMED justification for the adopted measure and justification file fields with browse button
  5. Provide the Date of entry into force for the measure:

    EUDAMED date of entry into force field
  6. Select the Precondition of lifting the measure. The drop-down list is the same for all procedure measures, and the option Other requires more information. Click Add another precondition to add more:

    EUDAMED precondition of lifting field and add another precondition link
  7. The Measure status cannot be changed. Provide the Measure status date, the Arguments by EO EUDAMED red closed padlock and any General remarks:

    EUDAMED measure status, measure status date, arguments by eo and general remarks fields
  8. Enter the CA contact information:

    EUDAMED fields in the ca contact information section
  9. Click Save and return later, or Submit. Click Cancel to remove all the modification on the page, without deleting the new measure:

    EUDAMED save, submit and cancel buttons

The measure is now viewable in the Measures by initiating CA & objections section:

EUDAMED discard button in the measures by initiating CA and objections tab

There is a Discard possibility, which removes the measure and all its versions from the procedure (State = Discard). However, the discarded measure information is still viewable in the management screen.

You can enter additional measures by clicking Add new measure.

Create a new measure

Create new version of a measure

Register a measure for another CA's procedure - create a new version

Discard a measure