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Post Market Performance Follow-up (PMPF) is a new term which appears in EU IVDR 2017/746, what does it mean? Post Market Performance Follow-up (PMPF) refers to proactive method of collecting and evaluating performance and relevant scientific data generated during the use of device already placed on market and is CE certified to conform to safety, performance and scientific validity. PMPF is a continuous process which updates performance evaluation and is a part of PMS plan.
The aim of PMPF studies-
PMPF is regulated as Annex III Part B of EU IVDR 2017/746. A manufacturer of In-vitro diagnostic devices is required to prepare a PMPF plan and an assessment report. PMPF is an important element of PMS plan and the main findings of PMPF are included in PMS report or Periodic Safety Update Report.
If PMPF is not deemed appropriate then a justification shall be provided and documented within the performance evaluation report.
Maven Profcon Services LLP. is a leading regulatory consultancy and our team IVD experts can provide support to IVD manufacturers for the following: