EU IVDR PMPF: Performance Follow-Up Plan & Report
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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 reporting requirements
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. The need for a dedicated study depends on unresolved performance questions, risks and applicable conformity-assessment conditions. Class C or D alone is not a complete study-design decision. 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.
Build a PMPF plan from the remaining evidence gaps
| Gap | Method to assess | Required control |
|---|---|---|
| Changing disease variants or population | Relevant performance data and literature | Defined specimen/population applicability |
| Uncertain real-world performance | Targeted study or structured data collection | Protocol, endpoints and statistical rationale |
| New signal or user issue | Investigation and proportionate follow-up | Link to risk, PER, labeling and corrective action |
Study authorization/notification depends on the design and applicable IVDR provisions, including additional invasive or burdensome procedures or use outside the intended purpose. Confirm ethics and national authority requirements before starting. Current EUDAMED arrangements do not make the CI/PS module universally mandatory.
Official framework and connected work
Use the current MDR, IVDR and Commission guidance for the applicable legal text and interpretation. Start from the EU market-entry hub for the overall pathway; this guide addresses the specific task within that program.
For regulatory terminology and the authority framework, see the EU MDR.
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Frequently asked questions
Not solely because of its class. Define the unresolved performance questions, current evidence and risks, then justify the methods. Applicable regulatory or conformity-assessment conditions can require specific additional data or studies.
Use the applicable national authority and ethics procedures for the study and participating countries. Determine whether the design requires authorization or notification under the relevant IVDR provisions; do not rely on an old projected module launch date.
Any nonapplicability conclusion needs a specific, documented justification based on the device and evidence. It does not remove the wider performance-evaluation, PMS or vigilance obligations, and should be reconsidered when evidence or intended purpose changes.
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