post-market monitoring
In plain wordsThe duty of an AI system's maker to keep watching how it performs after release, gathering evidence from real use so that problems are found and fixed.
The work a provider does after release to learn from how its AI systems are actually used, so that it notices promptly when something must be corrected or prevented. Under the EU AI ActEU AI Act, prop. n.: The European Union's law on artificial intelligence, the first broad AI law anywhere: it bans some uses, sets strict checks for risky ones and puts duties on the makers of the biggest AI models., providers of high-risk systemshigh-risk AI system, n.: Under EU law, an AI system used where mistakes could seriously hurt people's safety or rights — in hiring, schooling, loans, policing, borders or products like medical devices — and which must therefore pass strict checks. need a documented monitoring system, scaled to the technology and its risks, that keeps collecting and analyzing performance data for as long as a system is in use, drawing on deployers and other sources and, where relevant, on how the system interacts with other AI, to confirm that it still complies. The monitoring plan is part of the technical documentation. Findings feed into corrective action, withdrawal or recall, and serious incidentserious incident, n.: Under EU AI law, an AI failure that kills or badly injures someone, disrupts vital services, violates fundamental rights or seriously damages property — which the maker must report to authorities quickly. reporting.
Post-market monitoring showed the model's accuracy dropping for patients at the new clinic.
Origin
Adapted from post-market surveillance of medical devices and medicines (pharmacovigilance), where safety problems often appear only after wide use, and carried into AI law by the 2021 AI Act proposal. The 2026 Digital OmnibusDigital Omnibus, prop. n.: A European Union package, proposed in 2025, that simplified and delayed parts of its digital rules — above all pushing back the strictest requirements of the EU AI Act by more than a year. replaced a planned implementing act with Commission guidance and a template due by 2 September 2027.
Usage note
Technically it relies on model monitoringmodel monitoring, n.: Continuously checking an AI model after it goes live — what data it receives, what it predicts and whether it is still right — so that problems are caught before they cause harm. and data driftdata drift, n.: When the information flowing into an AI model in real use gradually stops resembling the data it was trained on — new customers, new slang, new cameras — making its predictions less reliable. detection from MLOps; the legal duty adds documentation, reporting and accountability.
Related
- serious incidentserious incident, n.: Under EU AI law, an AI failure that kills or badly injures someone, disrupts vital services, violates fundamental rights or seriously damages property — which the maker must report to authorities quickly.
- high-risk AI systemhigh-risk AI system, n.: Under EU law, an AI system used where mistakes could seriously hurt people's safety or rights — in hiring, schooling, loans, policing, borders or products like medical devices — and which must therefore pass strict checks.
- provider and deployerprovider and deployer, phr.: The two main roles in EU AI law: the provider is whoever makes an AI system and puts it out under its own name; the deployer is whoever uses it for work or official purposes.
- model monitoringmodel monitoring, n.: Continuously checking an AI model after it goes live — what data it receives, what it predicts and whether it is still right — so that problems are caught before they cause harm.
- AI incidentAI incident, n.: A real-world case in which an AI system, through a flaw, a breakdown or the way someone used it, ends up hurting people, property or rights, as in an injury, a wrongful arrest or a privacy breach.
- EU AI ActEU AI Act, prop. n.: The European Union's law on artificial intelligence, the first broad AI law anywhere: it bans some uses, sets strict checks for risky ones and puts duties on the makers of the biggest AI models.
Defined in law or standards
EU AI Act (Reg. (EU) 2024/1689), Art. 3(25) and Art. 72, as amended by Reg. (EU) 2026/1744
Mentioned in
high-risk AI systemhigh-risk AI system, n.: Under EU law, an AI system used where mistakes could seriously hurt people's safety or rights — in hiring, schooling, loans, policing, borders or products like medical devices — and which must therefore pass strict checks., AI incidentAI incident, n.: A real-world case in which an AI system, through a flaw, a breakdown or the way someone used it, ends up hurting people, property or rights, as in an injury, a wrongful arrest or a privacy breach., conformity assessmentconformity assessment, n.: The check, done by the maker or by an approved outside body, that a high-risk AI system meets the EU's legal requirements before it can be sold or used., provider and deployerprovider and deployer, phr.: The two main roles in EU AI law: the provider is whoever makes an AI system and puts it out under its own name; the deployer is whoever uses it for work or official purposes., serious incidentserious incident, n.: Under EU AI law, an AI failure that kills or badly injures someone, disrupts vital services, violates fundamental rights or seriously damages property — which the maker must report to authorities quickly., AI Incident DatabaseAI Incident Database, prop. n.: A free public online collection of reports about real cases in which AI systems caused or nearly caused harm, kept so that builders and regulators can learn from past failures., market surveillance authoritymarket surveillance authority, n.: The government body in each EU country that checks AI systems on the market, investigates complaints, and can order unsafe or unlawful AI to be fixed or withdrawn., substantial modificationsubstantial modification, n.: A change to an AI system after release that is big enough, under EU law, to require a fresh check — and that can make whoever made the change legally responsible as its maker.