--- title: "AI Act Post-Market Monitoring, Definition | MedTech Terms" description: "Ongoing, documented monitoring of a high-risk AI system's performance after it is placed on the market. Plain-English Regulatory definition for MedTech teams, w" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-post-market-monitoring#term", "name": "AI Act Post-Market Monitoring", "description": "Article 72 requires providers of high-risk AI systems to establish and document a post-market monitoring system proportionate to the nature of the AI technologies and the risks. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. AI Act Post-Market Monitoring [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Quality System](/ecosystems/quality-system) # AI Act Post-Market Monitoring Ongoing, documented monitoring of a high-risk AI system's performance after it is placed on the market. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 72 requires providers of high-risk AI systems to establish and document a post-market monitoring system proportionate to the nature of the AI technologies and the risks. The plan must actively and systematically collect, document, and analyse relevant data throughout the lifetime of the system to evaluate continuous compliance. ## What this means in practice For MedTech, the AI Act PMM plan should be integrated with the [MDR](/terms/mdr-reporting)/ [IVDR](/terms/ivdr) [post-market surveillance plan](/terms/pms-plan) and the [PMCF](/terms/pmcf)/ [PMPF](/terms/ivdr-pmpf) where required. Drift metrics, calibration checks, and real-world performance thresholds belong in both plans, not as parallel programmes. Common pitfalls - • Running two disconnected post-market programmes for the same device. Regulators expect one integrated view of performance. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory High-Risk AI System (EU AI Act) AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III. ](/terms/ai-act-high-risk-system)[ 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)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance) ### 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 (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [AI / ML in Devices](/ecosystems/ai-ml) - [Quality System](/ecosystems/quality-system) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 FDA· 1 European Commission· 1 1. [1 Regulation (EU) 2024/1689, Article 72 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1689/oj) 2. [2 FDA - Medical Devices Verified FDA fda.gov ](https://www.fda.gov/medical-devices) 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 Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ai-act-post-market-monitoring) Learn in 60 seconds Card Lesson Quiz Ongoing, documented monitoring of a high-risk AI system's performance after it is placed on the market. - · For MedTech, the AI Act PMM plan should be integrated with the MDR/IVDR post-market surveillance plan and the PMCF/PMPF where required. - · Drift metrics, calibration checks, and real-world performance thresholds belong in both plans, not as parallel programmes. - · The plan must actively and systematically collect, document, and analyse relevant data throughout the lifetime of the system to evaluate continuous compliance. Remember this Watch out: Running two disconnected post-market programmes for the same device. Regulators expect one integrated view of performance. Related terms - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) You may also need Auto-suggested from Regulatory and shared keywords. - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [CE Mark ](/terms/ce-mark) [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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