Post-Market Performance Follow-Up (IVDR)
Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF.
Definition
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.What this means in practice
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.Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56.
Manufacturer-maintained plan under Article 79 describing how safety and performance data are systematically collected once an IVD is on the market.
Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Annex XIII Part BVerifiedEUR-Lexeur-lex.europa.eu
- 2
MDCG 2022-2 Guidance on general principles of clinical evidence for IVDsUncheckedMDCGhealth.ec.europa.eu
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
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