PMPF

Post Market Performance Follow-up

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-

• Ensure Conformity to safety and performance of device throughout the lifetime of device
• To identify new risks or limitations to performance and contraindication
• Identifying and analysing emergent risks on the basis of factual evidence
• Ensure continued acceptability of clinical evidence and benefit- risk ratio
• Identify systematic misuse

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:

• Develop relevant strategy to generate all necessary data,
• Support the development of PMPF processes and plans and
• Helping with the successful implementation of PMPF activities
• Where deemed appropriate, justification for non-applicability of PMPF