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PSR information

  1. Under the PSR information tab, select one or more PSR types:

    PSR_Step3.png

    Note

    If the PSR type is related to incidents described in an FSCA, you have to additionally specify if the FSCA is registered in EUDAMED:

    PSR_Step3_FSCA.png

    Similarly, if the PSR type is Device-specific Vigilance Guidance, you must insert the relevant reference name in the mandatory field Device specific Vigilance Guidance (DSVG)? - Details:

    PSR_Step3_DSVG.png

  2. Provide at least one IMDRF code relating to the PSR in each of the three Annexes provided:

    PSR_Step3_IMDRF.png

  3. Next, provide the frequency of reporting for the PSR analysis update (the default value is three months):

    PSR_Step3_frequency.png

    Note

    If the value selected is other than the default three months, a rationale must be provided:

    PSR_Step3_frequency_rationale.png

  4. Finally, add other participating countries and their CAs:

    PSR_Step3_participating_countries.png

    Click Add to add more countries and their CAs, if needed:

    PSR_Step3_participating_countries_ADD.png