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Approval or Refusal of PSR update

Note

Once a PSR is updated by a MF or AR, the new version is saved in state Under approval and needs to be approved (or refused) by either a) the CCA or b) the CCA and participating CA(s) within seven calendar days.

All following updates require approval:

  1. Change the Coordinating Competent Authority (approval by the new CCA)

  2. Add Competent Authority(-ies) (approval by the added CAs)

  3. Extend the device scope (approval by the CCA and all CAs)

  4. Change the frequency of reporting (approval by the CCA)

  1. In order to approve a submitted PSR update, find and click on the relevant PSR from the Search and Manage Vigilance items page:

    EUDAMED Search and Manage Vigilance items page

  2. Inside the PSR, click on Approve PSR at the top right corner:

    EUDAMED PSR page and Approve PSR buton

    Alternatively, click Refuse PSR to reject it.

  3. In the pop-up window add any comments or an attachment if necessary and then click on Complete action:

    EUDAMED Pop-op window with Complete action button

Note

Approved state following a PSR update

The PSR's state will switch from Under approval to Approved and will be set to Active on the first day of the next period only when it is approved.

Upon approval or refusal of the updated PSR by the CCA and if applicable the participating CAs, the MF and/or AR, as well as any referenced NBs will receive information notifications.