--- title: "PMPF, Post-Market Performance Follow-up | MedTech Terms" description: "The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification. Plain-English Post-Market definition for MedTech teams" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pmpf#term", "name": "Post-Market Performance Follow-up", "alternateName": "PMPF", "description": "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).", "url": "https://medtechterms.com/terms/pmpf", "termCode": "pmpf", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/pmpf#article", "headline": "PMPF, Post-Market Performance Follow-up", "description": "The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification.", "url": "https://medtechterms.com/terms/pmpf", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/pmpf" }, "about": { "@id": "https://medtechterms.com/terms/pmpf#term" }, "articleSection": "Post-Market", "inLanguage": "en", "keywords": "Post-Market Performance Follow-up, PMPF, Post-Market, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-07-25", "dateModified": "2026-07-25", "citation": [ { "@type": "CreativeWork", "name": "Regulation (EU) 2017/746, Annex XIII Part B", "url": "https://eur-lex.europa.eu/eli/reg/2017/746/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "MDCG Vigilance Guidance", "url": "https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en", "publisher": { "@type": "Organization", "name": "MDCG" } }, { "@type": "CreativeWork", "name": "FDA MAUDE Database", "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm", "publisher": { "@type": "Organization", "name": "FDA" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr#term", "name": "EU In Vitro Diagnostic Regulation", "alternateName": "IVDR", "url": "https://medtechterms.com/terms/ivdr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-performance-evaluation#term", "name": "IVDR Performance Evaluation", "url": "https://medtechterms.com/terms/ivdr-performance-evaluation" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/psur-ivdr#term", "name": "PSUR (IVDR Specific)", "url": "https://medtechterms.com/terms/psur-ivdr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pmcf#term", "name": "Post-Market Clinical Follow-up", "alternateName": "PMCF", "url": "https://medtechterms.com/terms/pmcf" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Post-Market", "item": "https://medtechterms.com/terms?cat=Post-Market" }, { "@type": "ListItem", "position": 4, "name": "Post-Market Performance Follow-up", "item": "https://medtechterms.com/terms/pmpf" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/pmpf#faq", "mainEntity": [ { "@type": "Question", "name": "What is the primary goal of PMPF under the IVDR?", "acceptedAnswer": { "@type": "Answer", "text": "The primary goal of PMPF is to proactively collect and evaluate performance data from IVDs in real-world use to confirm their continued safety, performance, and clinical benefit, updating the performance evaluation accordingly." } }, { "@type": "Question", "name": "Is PMPF required for all IVDs?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, PMPF is required for all IVDs under the EU IVDR unless the manufacturer can provide a justified exemption, as outlined in IVDR Annex XIII Part B." } }, { "@type": "Question", "name": "How does PMPF relate to post-market surveillance (PMS)?", "acceptedAnswer": { "@type": "Answer", "text": "PMPF is a specific and systematic part of a manufacturer's overall post-market surveillance system, focusing on actively collecting performance data to update the performance evaluation and further characterize the IVD's performance and clinical utility." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Post-Market Performance Follow-up [All terms](/terms) Post-Market [Regulated Pathways](/ecosystems/regulated-pathways)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)PMPF # Post-Market Performance Follow-up The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification. 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) requires manufacturers to plan and conduct [PMPF](/terms/ivdr-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](/terms/psur) (Class C and D) or [PMS](/terms/post-market-surveillance) Report (Class A and B). What the regulation says The EU [IVDR](/terms/ivdr) (Regulation (EU) 2017/746) mandates Post-Market Performance Follow-up ( [PMPF](/terms/ivdr-pmpf)) as a continuous process to update the performance evaluation. This includes collecting and assessing performance and scientific data from the use of an [IVD](/terms/ivd) that bears the [CE mark](/terms/ce-mark), as specified in IVDR Annex XIII Part B. The FDA also expects manufacturers to monitor device performance post-market, although typically through [adverse event](/terms/adverse-event) reporting and other surveillance activities rather than a dedicated PMPF process as detailed in the IVDR. ## What this means in practice [PMPF](/terms/ivdr-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. ## Examples - A manufacturer of a novel immunoassay for a specific biomarker conducts PMPF by establishing a registry study to monitor assay performance in various clinical settings and patient populations over two years. - For an IVD used in point-of-care settings, the manufacturer implements a PMPF plan that includes active feedback channels from users and periodic site visits to observe device usage and collect performance data. - A company offering a high-risk companion diagnostic IVD includes a PMPF activity to track the incidence of false positive/negative results and their impact on patient management by collaborating with clinical laboratories. 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. ## Frequently asked questions What is the primary goal of PMPF under the IVDR? The primary goal of [PMPF](/terms/ivdr-pmpf) is to proactively collect and evaluate performance data from IVDs in real-world use to confirm their continued safety, performance, and clinical benefit, updating the performance evaluation accordingly. Is PMPF required for all IVDs? How does PMPF relate to post-market surveillance (PMS)? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market PSUR (IVDR Specific) Periodic Safety Update Report obligations for IVDs under EU IVDR Article 81. ](/terms/psur-ivdr)[ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Post-Market Post-Market Clinical Follow-up(PMCF) Proactive collection of clinical data on a CE-marked device to confirm safety and performance. ](/terms/pmcf)[ 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) ### IVDR Essentials · From this learning path [ Clinical & Trials Clinical Evaluation Plan(CEP) EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER). Adjacent lesson ](/terms/clinical-evaluation-plan?from=ivdr-essentials)[ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca?from=ivdr-essentials)[ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance?from=ivdr-essentials)[ Regulatory CE Mark Mandatory European conformity mark for medical devices placed on the EU market. ](/terms/ce-mark?from=ivdr-essentials) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [IVDR Essentials](/paths/ivdr-essentials)Lesson 8 of 13 Ecosystems (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 MDCG· 1 FDA· 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 Vigilance Guidance Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) 3. [3 FDA MAUDE Database Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [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 Post-Market Acronym PMPF Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=pmpf) Learn in 60 seconds Card Lesson Quiz The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification. - · 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. Remember this Watch out: Confusing PMPF with general post-market surveillance activities, as PMPF has specific requirements for data collection and analysis under the IVDR. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [PSUR (IVDR Specific) ](/terms/psur-ivdr) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) You may also need Auto-suggested from Post-Market and shared keywords. - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Post-Market Surveillance Plan ](/terms/pms-plan) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Periodic Safety Update Report(PSUR) ](/terms/psur) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)