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PSR Approval or Refusal – first version

Note

When a first version of a PSR has been submitted, the Coordinating Competent Authority (CCA) and the participating Competent Authorities have seven calendar days to either approve or refuse the PSR.

  • If the CCA does not perform any action within the 7-day deadline, the PSR is considered refused.

  • If the CA does not perform any action within the 7-day deadline, the PSR is considered refused by this CA, which means that this CA will not be participating in the PSR.

  1. From the EUDAMED dashboard, click on Manage Vigilance reports under the Vigilance tab:

    EUDAMED Dashboard with Manage Vigilance reports menu item selected

  2. Find and click on the relevant PSR inside the section Search and Manage Vigilance items:

    EUDAMED Search and Manage Vigilance items section with list display of My Vigilance items

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

    EUDAMED Approve PSR button

    Alternatively, click Refuse PSR to reject it:

    EUDAMED Refuse PSR button

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

    Approval by CA example:

    EUDAMED Pop-up window for approval with Comments field, attachment option and Complete action button

    Refusal by CA example:

    EUDAMED Pop-up window for refusal with Comments field, attachment option and Complete action button

Note

Approved state

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

Ultimately, the CCA's decision overrules that of the CA, i.e. the participating CA's approval alone is not enough for the PSR to be approved. If the CCA refuses the PSR, the PSR is refused regardless of any approval by a participating CA.

Once a PSR is submitted, you can view the approval state of the PSR under section Action history overview.

Example: the participating CA has approved the PSR whereas the CCA's approval is pending:

EUDAMED CA approval example under PSR Report history overview section

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

Notification example: PSR approval by the CCA:

EUDAMED Approval notification example

Notification example: PSR refusal by the CCA or deadline lapsed:

EUDAMED Refusal notification example