Annex XIII Part B of the IVDR requires manufacturers to plan and conduct PMPF as a continuous process that updates the performance evaluation. The PMPF plan specifies methods and procedures for collecting and evaluating clinical performance and safety data, and results are reported in a PMPF Evaluation Report that feeds the Performance Evaluation Report and the PSUR (Class C and D) or PMS Report (Class A and B).

Why it matters

PMPF is not optional. When a manufacturer concludes PMPF is not applicable, the rationale must be documented and justified. Registry participation and reflex-testing agreements with clinical laboratories are common PMPF data sources.

Common pitfalls

•Confusing PMPF with general post-market surveillance activities, as PMPF has specific requirements for data collection and analysis under the IVDR.
•Failing to establish a PMPF plan or justify its absence for every IVD, which is a key IVDR requirement.
•Not sufficiently linking PMPF findings back to the performance evaluation report and clinical evidence, thus missing the iterative improvement aspect.
•Using only passive surveillance data for PMPF when active data collection is necessary to address specific performance questions.
•Underestimating the resources and expertise required to effectively conduct PMPF activities and analyze the resulting data.

Sources

Regulation (EU) 2017/746, Annex XIII Part B · EUR-Lex
MDCG Vigilance Guidance · MDCG
FDA MAUDE Database · FDA

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