With the IVDR deadline of May 2022 quickly approaching, it’s time for manufacturers to start planning how they will address the new PMPF requirements. The small number of notified bodies approved for the IVDR will create a bottleneck that cannot be overlooked.
The conclusions of the PMPF will be documented in the PER. For the higher risk class devices, such as Class C and D, the PER is expected to be updated at least annually which means that the PMPF report should be updated annually as well. Important updates of the PMPF report shall also be included in the PSUR (Periodic safety update report for Class C and D) and in the Summary of Safety and Performance (SSP), which shall be updated as soon as possible, where necessary.
Thus, it is critical for manufacturers to have a robust PMPF plan since many linked documents also must be updated to remain compliant with the IVDR.