EU PMPF Post-Market Performance Follow-Up for IVDs
PMPF is an ongoing process to collect and evaluate performance and scientific data from the use of your device on the market.
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.
Frequently
Asked Questions
When do we need to notify EU Member States about conducting PMPF studies?
Before beginning a PMPF study that will assess the device when used outside its intended purpose, the study Sponsor must submit an application to all Member States where the study will be conducted via the Clinical Investigations/Performance Studies (CI/PS) Module in EUDAMED (still in development – expected to be released in end 2025) or through the databases from national competent authorities (NCA) in all Member States, where the PMPF study is conducted. If the study will submit subjects to processes that are considered “invasive or burdensome” according to Article 70 of the IVDR, Sponsors must notify relevant Member States at least 30 days before the study begins.
How should performance study applications be submitted until the CI/PS module is available in EUDAMED?
Until EUDAMED CI/PS module is live, manufacturers and Sponsors must submit individual PMPF performance study applications to each Member State where the study will be performed. The processes in the EU Member States differ through national legislation and may require ethical favourable opinion as well as approval from NCA. The application and review process may also differ and may require different elements of the Technical Documentation such as General Safety Performance Requirements Checklist. Manufacturers and Sponsors must be proactive when planning the application process as well as planning for potential delays.
What if PMPF isn’t necessary for my device?
PMPF is a general requirement under IVDR, but may not be necessary for some low-risk devices. If you feel PMPF is not needed for your device, you must thoroughly justify your exemption in the PMPF report. A PMPF plan and a PMPF report as well as a PMPF procedure (part of your QMS) is still required under IVDR. The PMPF activities should link to the risk management, performance evaluation, and PMS activities and update them, as needed.
