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Create initial PSRP dossier

Note

A PSRP (PSR Periodic Analysis Update) must be linked to an active PSR and serves as a tool for periodic reporting updates after the PSR period has elapsed.

Keep in mind that if a PSRP has already been created for a specific PSR period, it is not possible to create another PSRP for the same period. The PSRP can however be updated (new version).

  1. From the EUDAMED dashboard, click on Register a new Vigilance Form under the Vigilance section:

    vigilance-register-form.png

  2. Select the PSRP template from the drop-down list:

    PSRP_create_dossier.png

  3. Select the manufacturer from the Manufacturer field:

    PSRP_create_dossier2.png

    The system will automatically retrieve your Actor information.

  4. Enter the Manufacturer reference.

  5. Select the PSR ID you wish to link the PSRP to:

    PSRP_create_dossier3.png

    Tip

    The system will only display PSRs for which a new PSRP can be created.

  6. Click on Create Form to complete this initial step.

Important

The information provided in this step cannot be modified after you click Create form.