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Update PSR (create new version)

Note

Once a PSR is submitted, the MF/AR can update it and the update will be saved as a new version, pending CCA/CA approval (Under approval state).

Important:

In the 1st PSR period, the update can be done as soon as the PSR is in status Active.

In the subsequent periods, a PSR update can only be done after the PSRP assessment for the period has been completed.

Once a PSR is submitted, it can be updated and the update will be saved as a new version.

Note

There are five possible types of updates in a PSR:

  1. Change the Coordinating Competent Authority: put another CA in charge of coordinating this specific PSR (CA approval required)

  2. Add Competent Authority(-ies): add other participating CA(s) to this specific PSR (CA approval required)

  3. Extend the device scope: add more devices (CA approval required)

  4. Change the frequency of reporting: (CCA approval required)

  5. Update other fields: all other possible updates (no approval required)

Only one of these update types can be performed at a time.

Depending on the update selected, only the relevant sections will become accessible for updating. All other sections remain locked, therefore please pay attention to the update button clicked, as each workflow varies.

  1. Access the PSR you wish to update via the Search & Manage Vigilance items page:

    PSR_search_view.png

  2. Inside the PSR, click on one of the five update options at the top:

    PSR_update.png

    In the present example the CCA is updated.

  3. Click on Complete action in the pop-up window, to confirm the initiation of a new PSR version:

    PSR_update_popup.png

  4. Navigate to the editable section(s) and update the relevant fields, e.g.:

    PSR_modify_fields.png

  5. Click on Submit at the top right of the screen:

    PSR_click_submit.png

  6. Click on Complete action in the pop-up window, to submit the new PSR version:

    PSR_complete_update.png

    The newly created version is logged under CA Status & History.

    Note

    Following the submission of the update, action or information notifications will be sent to involved actors. E.g. in the case of a CCA update, the newly selected CCA will receive a notification to approve or reject the update within seven calendar days.