Purpose and scope
Which system, which version, which intended purpose, which places of use. Also what is expressly not covered, for example deployers who make their own adaptations.
Guide · Post-market monitoring
Updated 6 October 2026 · AI Act as amended by Regulation (EU) 2026/1744
A high-risk AI system is not finished once the conformity assessment is done. Article 72 requires providers to observe performance in operation systematically, based on a documented plan. Deployers monitor under Article 26(5) and feed back what they see. This guide shows how the two fit together.
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Short answer
Under Article 72 of the AI Act, providers of high-risk AI systems must establish and document a post-market monitoring system. It is based on a plan that forms part of the technical documentation and collects performance data throughout the system’s lifetime. Deployers monitor operation under Article 26(5) on the basis of the instructions for use and inform the provider of anything unusual.
What this is about
The conformity assessment examines a high-risk AI system at a given point in time with given data. In operation, both change: input data shifts, users work with the system differently than planned, models are retrained, connected services change version. The AI Act answers this with post-market monitoring. Article 3(25) describes it as all activities by which providers collect and review experience gained from the use of their systems in order to identify any need to take corrective or preventive action immediately.
That purpose matters more than any single metric. Monitoring in the sense of the Regulation is not a reporting exercise but an early-warning system with a decision path. A dashboard nobody reviews does not serve the purpose. A modest but regularly reviewed set of logs, feedback and a few well-chosen metrics comes much closer – provided it is documented who decides what when a deviation appears.
For mid-sized organisations the question of role is decisive. Whoever develops a high-risk AI system and places it on the market under their own name is the provider and needs the Article 72 plan. Whoever uses a purchased system under their own authority is the deployer and monitors under Article 26(5), with their own duties to inform the provider and the authority. Each side depends on the other: without deployer data the provider lacks the view from the field; without provider information the deployer lacks a yardstick.
Legal basis
Article 72 does not stand alone. Risk management, logging, quality management, corrective action and deployer duties interlock. The table sorts the provisions by content, addressee and practical consequence.
Scroll the table sideways →
| Provision | Content | Addressee | What it means in practice |
|---|---|---|---|
| Art. 3(25) | Definition: all activities by providers to collect and review experience from use, to identify any need for immediate corrective or preventive action. | Provider | Every metric needs a decision attached. Anything that cannot trigger an action does not belong in the core of the plan. |
| Art. 72(1)–(2) | Establish and document the system, proportionate to the technology and risks; actively and systematically collect, document and analyse performance data – including data from deployers or other sources – throughout the lifetime; evaluate continuous compliance with Chapter III Section 2; where relevant, analyse interaction with other AI systems. | Provider | Name data sources per system and make deployer feedback contractually possible. Sensitive operational data of law-enforcement deployers is excluded. |
| Art. 72(3), Annex IV point 9 | The system is based on a plan; the plan is part of the technical documentation. The Commission adopts guidelines including a template for the plan. | Provider | Until the template is published, work with your own traceable structure and map it later. |
| Art. 72(4) | For products under Annex I Section A with an existing monitoring system, and for Annex III point 5 systems of regulated financial institutions, the elements may be integrated into existing systems and plans, provided an equivalent level of protection is achieved. | Providers of regulated products, financial institutions | No parallel process needed: hook the AI part into your existing market surveillance or governance. |
| Art. 9(2)(c) | Risk management evaluates other risks on the basis of data gathered by the Article 72 system. | Provider | Monitoring results flow back into the risk register, where new risks are assessed and given measures. |
| Art. 12(2) | Logging must capture events relevant to risk situations and substantial modifications, to post-market monitoring under Article 72 and to deployer monitoring under Article 26(5). | Provider (system design) | Design logs so that the plan’s metrics can be derived from them – rather than discovering gaps afterwards. |
| Art. 19, Art. 26(6) | Keep automatically generated logs to the extent they are under your control, for a period appropriate to the intended purpose of at least six months, unless other law provides otherwise. | Provider, deployer | Align the retention period with your deletion policy; personal data in logs needs a GDPR justification for the period. |
| Art. 17(1)(h), (i); 17(2) | The quality management system covers setting up and operating post-market monitoring under Article 72 and procedures for reporting serious incidents; scope proportionate to the size of the organisation. | Provider | Run the plan as a controlled QMS document: version, approval, owners, review cycle. |
| Art. 20 | Where there is reason to consider a system non-compliant, take corrective action immediately, or withdraw, disable or recall it; inform distributors and, where applicable, deployers. Where there is a risk under Art. 79(1): investigate causes and inform the market surveillance authorities. | Provider | Set out in the plan which threshold breach triggers a review for corrective action – and who orders it. |
| Art. 26(5) | Deployers monitor operation on the basis of the instructions for use and, where relevant, inform providers in line with Article 72; where there is a risk under Art. 79(1), inform the provider or distributor and the authority and suspend use; for a serious incident, inform first the provider, then the importer or distributor and the authorities. | Deployer | Record the reporting route to the provider, with contact and response time, in the contract; define suspension criteria in advance. |
| Art. 73(2)–(4) | Reporting serious incidents to the market surveillance authority: no later than 15 days after becoming aware; no later than 2 days for a widespread infringement or critical infrastructure; no later than 10 days in the event of death. | Provider (deployer if the provider cannot be reached) | Monitoring produces the finding that starts the clock. The reporting process itself belongs in the incident procedure. |
| Art. 3(23), Art. 43(4), Art. 25(1) | Substantial modification: not foreseen or planned and affecting compliance with the requirements or the intended purpose. Consequence: a new conformity assessment; pre-determined changes of systems that continue to learn are not substantial. Whoever makes a substantial modification may become the provider. | Provider, deployer, third parties | Monitoring checks every model and data change against the pre-determined changes in Annex IV point 2(f). |
Wording checked on 6 October 2026 on ai-act-law.eu (consolidated text after Regulation (EU) 2026/1744). The text published in the Official Journal is authoritative.
How it works
The order is a recommendation. It assumes that inventory and risk classification are in place – without them you cannot say which system needs a plan in the first place.
Filter the high-risk systems out of the AI inventory and record for each whether you are provider or deployer. Look closely at in-house developments, rebranded products and heavily adapted systems – this is where the provider role often arises unnoticed.
Take from validation and the instructions for use the values against which operation is measured: levels of accuracy and their metrics, performance for specific groups of persons, known limitations. Without a reference, no deviation can be detected.
Decide where the insight comes from: automatically generated logs, deployer feedback, complaints from affected persons, technical monitoring tools. For each source, settle who has access and how long data may be kept.
Pick a few meaningful metrics and set a threshold and an escalation level for each. The threshold follows from the reference value and the risk – not from industry benchmarks.
Approve the plan as a document of the technical documentation, with version, owners and review date. From here on it is the basis for any review – including by the authority.
Automated alerts run all the time; the expert review follows the agreed rhythm. Every threshold breach is documented as a case with its outcome – even if the suspicion is not confirmed.
Two questions after every relevant finding: is there a serious incident that must be reported? And has the system changed in a way that requires a new conformity assessment?
At least once a year and after every major event, check whether metrics, thresholds and sources still fit. Once the Commission template is published, map your structure to it.
For deployers the chain is shorter: steps 1 to 3 and 6 make sense for them too, while approving an Article 72 plan and the conformity question rest with the provider – as long as the deployer does not become a provider itself.
Roles
Both roles monitor, but with different aims. The provider assesses whether the product still meets the requirements. The deployer checks whether use in its own organisation matches the instructions for use and whether risks emerge.
A common misconception is: “We only buy, so we do not need to monitor anything.” Article 26(5) expressly requires deployers to monitor operation. The duty is leaner than the provider’s, but it is not optional. In practice, the oversight staff under Article 26(2) need a clear way to report anomalies, and someone has to collect those reports and pass them on to the provider.
Conversely, the provider cannot meet its duty without deployers. Article 72(2) expressly names data provided by deployers as a source. We recommend recording in the contract which data the deployer supplies in which form, how feedback is transmitted and how quickly the provider responds. That turns a general expectation of cooperation into a process that can be checked.
Scroll the table sideways →
| Topic | Provider | Deployer |
|---|---|---|
| Legal basis | Art. 72, supplemented by Art. 9, 12, 17, 19, 20 | Art. 26(5) and (6), supplemented by Art. 26(2) and (4) |
| Aim | Evaluate continuous compliance with Chapter III Section 2 | Ensure operation in line with the instructions for use, detect risks |
| Data | Performance data across the lifetime, including from deployers and other sources | Own observation, logs under own control, reports from oversight staff |
| Document | Post-market monitoring plan as part of the technical documentation | No Article 72 plan required; documented monitoring recommended |
| Logs | Keep, to the extent under control, for at least six months (Art. 19) | Keep, to the extent under control, for at least six months (Art. 26(6)) |
| Anomaly | Analysis, corrective action and information under Art. 20 where needed | Inform the provider (Art. 26(5), first sentence) |
| Risk under Art. 79(1) | Investigate causes, inform the market surveillance authorities (Art. 20(2)) | Immediately inform the provider or distributor and the authority, suspend use |
| Serious incident | Report under Art. 73 to the market surveillance authority | Immediately inform first the provider, then the importer or distributor and the authorities; provider unreachable: Art. 73 applies mutatis mutandis |
| Changes to the system | Check for substantial modification, new conformity assessment where needed (Art. 43(4)) | Own substantial modification turns you into the provider (Art. 25(1)(b)) |
The plan
The Regulation requires the plan but prescribes no structure. The Commission template under Article 72(3) is still pending. The following eight sections work well as a structure and can be mapped to the template later.
Which system, which version, which intended purpose, which places of use. Also what is expressly not covered, for example deployers who make their own adaptations.
Logs, deployer feedback, complaints, technical monitoring, support reports. For each source: format, access, retention, data protection basis.
A few indicators with a clear origin for their reference value from validation or the instructions for use. Performance for groups of persons separately where the system is applied to people.
A threshold and a level per metric: observe, review, intervene, report. Plus who decides at each level and within what time.
What is checked automatically and continuously, what is reviewed by experts at fixed intervals, and which events trigger an extra review.
One person who owns the plan and named roles for metrics, complaints, the reporting decision and approval of corrective action – with deputies.
Where reviews, cases and decisions are kept, for how long, and how they link to the technical documentation, the risk register and the QMS.
When the plan itself is reviewed, how changes are approved and how model or data changes are checked against the pre-determined changes.
This structure is an editorial recommendation, not an official requirement. Once the Commission publishes guidelines and a template, existing plans should be mapped to it.
Interactive
Choose role, system type, data sources and review rhythm. The builder produces a structured draft with article references that you can copy as text into your documentation. For deployers it produces a draft for monitoring under Article 26(5) instead. Everything is a recommendation, not legal advice.
Draft plan
Post-market monitoring (Art. 72)
Post-market monitoring plan – draft
Draft and recommendation, not legal advice. Provisional structure until the Commission template under Article 72(3) AI Act is available.
Basis: Art. 3(25), Art. 72(1)
Basis: Art. 72(2), Art. 12(2)
Basis: Art. 72(2), Art. 9(2)(c), Art. 13(3)(b), Art. 15
Basis: Art. 72(2) (active and systematic)
Basis: Art. 17(1)(m)
Basis: Art. 20, Art. 73(2)–(6)
Basis: Art. 72(3), Annex IV point 9, Art. 18, Art. 19
Basis: Art. 9(2), Art. 3(23), Art. 43(4)
This draft is a working aid from the SimpleAct editorial team and not legal advice. Thresholds and times for escalation levels 1 to 3 are recommendations; the Article 73 deadlines are binding.
Metrics
There is no statutory list of metrics. The yardstick is what shows continuous compliance with accuracy, robustness, cybersecurity, human oversight and data quality. The thresholds in the table are examples and must be adapted to your own reference values.
Two metrics deserve particular attention because many plans lack them. First, error rates by group of persons: overall accuracy can stay stable while performance for one group deteriorates markedly. Where the system is applied to people, the instructions for use under Article 13(3)(b) must state performance regarding specific persons or groups – those statements are the natural reference value.
Second, the override rate: the share of cases in which human oversight rejects the system’s recommendation. If it rises sharply, that points to declining quality. If it drops towards zero, it may indicate automation bias – oversight that merely rubber-stamps. Both are monitoring findings, not just staffing issues.
Generative systems have a particular feature: classic accuracy measures often do not apply. Regular samples with fixed assessment criteria, and the rule that every change of the underlying model is treated as an event, have proved useful. Whether an LLM assistant is high-risk at all depends on its use, for example in an area listed in Annex III – not on the technology.
Scroll the table sideways →
| System type (example) | Typical metrics | Example threshold (recommendation) | Typical source |
|---|---|---|---|
| Classification and scoring, e.g. candidate screening or creditworthiness | Accuracy or AUC against reference; error rates by group of persons; drift in the main features; override rate of human oversight; objections | Accuracy drop of more than 3 percentage points; gap in false-positive rates between groups above 5 percentage points; override rate twice that of the baseline month | Logs, samples with later known outcome, oversight decisions |
| Generative AI, e.g. an LLM assistant in a high-risk process | Error rate in samples; share of blocked or later corrected outputs; escalations to humans; change of model version; complaints | Sample error rate above the validation value; every version change of the base model triggers a review | Logs, sample review, release events, support |
| Image and biometrics, e.g. identity matching | False-positive and false-negative rate, by group; quality of input images; confirmation rate by reviewers | False-positive rate above the value stated in the instructions for use; unusable inputs above 10 % | Logs, review records, technical monitoring |
| Forecasting, e.g. demand or load forecasts | Forecast error against actuals; drift in inputs; share of manual corrections; failed and delayed runs | Mean forecast error above the validation value for two consecutive periods; every failed run in critical time windows | Actuals, technical monitoring, operating logs |
| All types | Availability and outages; security events; complaints and reports; use outside the intended purpose | Every complaint indicating discrimination is reviewed individually; use outside the intended purpose is always level “review” | Support, complaints channel, deployer feedback |
Thresholds and escalation
A threshold without a consequence is decoration. We recommend assigning each metric an escalation level and setting, for each level, who decides within what time. The times in the table are examples; the statutory deadlines are in the last row.
What matters is the separation between automated alert and expert assessment. An alert from the monitoring tool is a prompt, not a decision. Whether level 3 or 4 applies is decided by a person with a documented rationale. It is exactly that rationale an authority will ask for later – not the raw alert data.
Equally important: false alarms belong in the record too. A plan showing that anomalies were reviewed and dismissed with reasons demonstrates a working system. A plan without a single case over twelve months raises the question of whether anyone is looking at all.
Scroll the table sideways →
| Level | Trigger (example) | Response (recommendation) | Legal reference |
|---|---|---|---|
| 1 – Observe | Metric approaching the threshold, single complaint without a pattern | Note, closer observation until the next review | Art. 72(2) |
| 2 – Review | Threshold exceeded, cluster of similar feedback, use outside the intended purpose | Root-cause analysis within a few working days, document the outcome, update the risk register | Art. 9(2)(c) |
| 3 – Intervene | Non-compliance likely or risk to health, safety or fundamental rights | Corrective action, withdrawal or disabling where needed; inform distributors and deployers; for a risk under Art. 79(1), the market surveillance authority | Art. 20; Art. 26(5) for deployers |
| 4 – Report | Serious incident within the meaning of Art. 3(49) | Start the reporting procedure; do not alter the system in a way that may affect later evaluation of the causes before informing the authorities | Art. 73: no later than 15 days; 2 days for a widespread infringement or critical infrastructure; 10 days in the event of death |
Interface to Article 73
In most cases monitoring is where a serious incident first becomes visible: as an outlier in a metric, as a complaint, as a report from a deployer. The Article 73 deadlines run from awareness. The report must be made immediately after the provider has established a causal link between the AI system and the incident, or the reasonable likelihood of such a link – and no later than 15 days after becoming aware, or 2 or 10 days in the special cases. An incomplete initial report is permitted.
For the plan this means it must ensure relevant reports do not sit in an inbox. We recommend specifying in the plan that every level-3 finding is immediately checked for a reporting duty as well, and who carries out that check. For deployers there is an additional rule: a serious incident goes immediately to the provider first; if the provider cannot be reached, Article 73 applies mutatis mutandis.
The details – content of the report, competent authority, interplay with GDPR or NIS2 notifications, the investigation under Article 73(6) – are covered in our incident management guide. In Germany the KI-MIG makes the Federal Network Agency (Bundesnetzagentur) the market surveillance authority in principle, and BaFin for certain financial activities.
Further reading: the guide “Incident management under Article 73”, linked at the end of this page.
Substantial modification
Besides incidents, monitoring can produce a second, often overlooked finding: the system has changed so much that the original conformity assessment no longer covers it. Article 3(23) defines a substantial modification as a change after placing on the market that was not foreseen or planned in the initial conformity assessment and that affects compliance with the requirements or changes the intended purpose. Article 43(4) then requires a new conformity assessment procedure.
For systems that continue to learn there is an important exception: changes the provider pre-determined at the time of the initial conformity assessment and described in the technical documentation under Annex IV point 2(f) do not count as a substantial modification. Monitoring is the tool that shows a system has stayed within that pre-described corridor.
For deployers the finding has its own weight. Whoever makes a substantial modification to a high-risk AI system so that it remains high-risk is considered a provider under Article 25(1)(b) – with all Article 16 duties, including its own Article 72 plan. In-house retraining, swapping components or a new purpose should therefore be checked in advance.
Timing
Articles 72 and 73 attach to high-risk AI systems. Following amending Regulation (EU) 2026/1744, the high-risk requirements in Chapter III Sections 1 to 3 apply to Annex III systems from 2 December 2027 and to Annex I systems from 2 August 2028. From those dates the plan and monitoring become relevant in practice. Anyone placing systems on the market by then should not write the plan on the deadline: it depends on logs, reference values and deployer contracts that cannot be retrofitted at short notice.
For small and medium-sized enterprises and small mid-caps, Article 17(2) allows proportionate quality management. Article 72(1) likewise requires a system proportionate to the technology and the risks. A manageable plan with a few metrics, clear responsibilities and actual review is better than an extensive document nobody maintains.
For systems that are not high-risk, the AI Act does not require post-market monitoring. We still recommend a light form of monitoring – for a service chatbot, say – because purposes shift and complaints and malfunctions have to be handled anyway.
Common mistakes
SimpleAct
Measurement happens where your team already works. SimpleAct takes alerts and release events from those tools and assigns them to the relevant AI system – so that review, decision and evidence sit in one place.
According to the product documentation, event ingestion (runtime signals) is included in the Professional plan as part of incident management. SimpleAct replaces neither your monitoring tool nor the expert assessment.
Open-Source Framework
simpleact-incident-management
Open procedure for post-market monitoring under Art. 72 and incident reporting under Art. 73 AI Act, with two separate clocks.
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Updated: · SimpleAct editorial team
This guide is general information and not legal advice. Examples and thresholds are editorial recommendations. Please seek qualified advice to assess your specific system.
See in a demo how alerts and releases from your tools arrive as evidence in the system – or try SimpleAct yourself.