Annex XIII Part B of the IVDR defines PMPF as a continuous process that updates the performance evaluation and is addressed in the manufacturer's post-market surveillance plan. Its objectives include confirming safety and performance throughout the expected lifetime, identifying previously unknown risks, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse.

Why it matters

PMPF is not optional: where a manufacturer justifies that PMPF is not applicable, that justification itself must be documented and defended in the Performance Evaluation Report. Common PMPF activities include real-world performance studies, registry participation, external quality assessment (EQA) programme data, and structured user surveys.

Common pitfalls

•A common mistake is treating PMPF as a one-time activity or an optional requirement; manufacturers must have a continuous process and justify its inapplicability if not pursued.
•Manufacturers often fail to adequately integrate PMPF into their overall quality management system, leading to fragmented data collection and evaluation processes.
•Another misconception is limiting PMPF activities to only complaint data, overlooking proactive measures like real-world studies or user surveys that provide richer performance insights.

Sources

Regulation (EU) 2017/746, Annex XIII Part B · EUR-Lex
MDCG 2022-2 Guidance on general principles of clinical evidence for IVDs · MDCG
European Commission - Medical Devices · European Commission

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