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Initial Manufacturer PSR analysis

  1. Under the Initial Manufacturer PSR analysis tab, fill in the mandatory fields:

    PSR_Step5_1.png

  2. Answer the question Has the risk assessment been reviewed?

    • If Yes, specify if the risk assessment is still adequate and its results:

      PSR_Step5_2.png

    • If No, explain the rationale for no review:

      PSR_Step5_3.png

  3. Fill in the fields in the Similar incidents section:

    PSR_Step5_4.png

    • Choose minimum one IMDRF code option.

    • Choose the identification basis variant of similar incidents.

    • Choose the criteria of the number of devices on the market.

    • Provide comments on how similar incidents and associated number of devices were determined.

  4. Provide the number of similar incidents and devices on the market for the indicated time periods in the past:

    PSR_Step5_5.png

    Note

    Time period (N) stands for the current calendar year (the year in which the PSR is being submitted) and is a mandatory field.

    If you need to enter data for years preceding Time period N, you have the option of selecting the corresponding N-(x) period and follow the same process:

    PSR_Step5_6.png

    Example of data entered for time period N-1 (one calendar year prior to the present PSR):

    PSR_Step5_7.png