What is Post-Market Performance Follow-up?
When the In Vitro Diagnostic Devices Regulation (EU) 2017/746 (IVDR) replaced the In Vitro Diagnostic Directive in 2022, it introduced the concept of Post-Market Performance Follow-up (PMPF) to complete the full life cycle approach. According to Annex XIII, Part B of the IVDR, PMPF is an ongoing process to collect and evaluate performance and scientific data from the use of your device on the market to ensure it remains safe and performs as intended. PMPF is a cornerstone of your ongoing Performance Evaluation (PE), risk management, and Post-Market Surveillance (PMS) activities and reporting requirements.
PMPF data can and should come from a range of sources and methods, such as:
- clinical experience,
- feedback from users,
- scientific literature,
- ring trials,
- epidemiological studies,
- patient or disease registers,
- post-market clinical performance studies.
Even though PMPF is a regulatory obligation, PMPF data can also inform enhancements to the device design that improve usability or effectiveness, expand its intended purpose, and refine claims made about your device.
Post-market performance follow-up PMPF reporting requirements under the IVDR
PMPF is documented in two stages: a PMPF plan and PMPF report. The PMPF plan explains how you intend to approach PMPF activities, including methods, objectives, and timelines, as well as justifications for your plan details based on the performance evaluation and risk management data.
The PMPF report documents your findings, analyses, and conclusions and should include favorable and unfavorable data. It is part of your Technical Documentation and Performance Evaluation Report (PER), and informs your PMS/PSUR Report. The PMPF plan and report should be updated throughout the device’s life cycle.
When to conduct a PMPF study
Post-market performance follow-up (also called post-market clinical performance) studies are a key source of PMPF data but may not be necessary for all devices. However, if your IVD is Class C or D, you can count on conducting performance PMPF studies as part of your post-market requirements. In some cases, you may be required to conduct a PMPF study regardless of your device classification, such as in scenarios where:
- New concerns arise about device safety or performance from other PMPF or PMS data.
- Your device is approved for a new indication, patient or user population, etc.
- A PMPF study was requested by your Notified Body or regulator.
