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Opt out of a PSR as Participating CA

Participating CAs may choose to participate or stop participating in a PSR; this is an action that becomes effective either:

  • from the beginning of the current period, or

  • from the start of the next period.

Tip

A participating CA can opt out of a PSR either via:

a) the relevant PSR itself, or

b) a linked PSRP (in case there are PSRPs attached to the specific PSR).

A. PSR path

  1. Access the relevant PSR from Search and Manage Vigilance items:

    EUDAMED Search and Manage Vigilance items page
  2. Inside the PSR, click on the button Stop participating in PSR (from the next period):

    EUDAMED Stop participating in PSR button
  3. In the pop-up window add any comments if necessary, and click on Complete action to finalise the action:

    EUDAMED PSR Pop-up window with Complete action button

B. PSRP path

Note

Participating CAs receive an action notification to make an assessment on a new PSRP. A participating CA may perform the PSR opt-out via the PSRP path when the first version of a PSRP is submitted (Submitted state).

  1. Access the relevant PSRP via Search and Manage Vigilance items:

    EUDAMED Search and Manage Vigilance items page
  2. Inside the PSRP, click on the button Stop participating in PSR (from the beginning of the current period):

    EUDAMED PSRP page with Stop participating in PSR button
  3. In the pop-up window add any comments if necessary, and click on Complete action to finalise the action:

    EUDAMED PSRP Pop-up window with Complete action button