--- title: "PMPF Definition & Meaning | MedTech Terms" description: "Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-pmpf#term", "name": "Post-Market Performance Follow-Up (IVDR)", "alternateName": "PMPF", "description": "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. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Post-Market Performance Follow-Up (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)PMPF # 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. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Annex XIII Part B of the [IVDR](/terms/ivdr) defines [PMPF](/terms/pmpf) as a continuous process that updates the performance evaluation and is addressed in the manufacturer's [post-market surveillance plan](/terms/pms-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 the regulation says Annex XIII Part B Section 5.1 states that [PMPF](/terms/pmpf) shall be understood to be a continuous process that updates the performance evaluation referred to in Article 56 and Part A of this Annex. ## What this means in practice [PMPF](/terms/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 theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory IVDR Performance Evaluation Continuous, systematic process to generate, collect, analyse, and assess data demonstrating an IVD's performance under IVDR Article 56. ](/terms/ivdr-performance-evaluation)[ Regulatory Post-Market Surveillance Plan (IVDR) Manufacturer-maintained plan under Article 79 describing how safety and performance data are systematically collected once an IVD is on the market. ](/terms/ivdr-pms-plan)[ Post-Market PSUR (IVDR Specific) Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81. ](/terms/psur-ivdr) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement 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. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 1 MDCG· 1 European Commission· 1 1. [1 Regulation (EU) 2017/746, Annex XIII Part B Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 MDCG 2022-2 Guidance on general principles of clinical evidence for IVDs Unchecked MDCG health.ec.europa.eu ](https://health.ec.europa.eu/document/download/23f3d5b7-c9f3-46a0-ab5b-2c9f3d5b7e4b_en) 3. [3 European Commission - Medical Devices Verified European Commission health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym PMPF Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-pmpf) Learn in 60 seconds Card Lesson Quiz Continuous process of proactively collecting and evaluating performance data on an IVD after CE marking, analogous to MDR PMCF. - · 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. Remember this Annex XIII Part B Section 5. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [PSUR (IVDR Specific) ](/terms/psur-ivdr) You may also need Auto-suggested from Regulatory and shared keywords. - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) - [CE Mark ](/terms/ce-mark) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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