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Across 10 modules • Updated Jul 25, 2026
Author
Sorena AI
Published
May 9, 2026
Updated
Jul 25, 2026
EU AI Act Article 73 serious incident

What timing and follow-up steps should the provider track under Article 73?

Article 73 requires reporting immediately after the provider establishes a causal link or reasonable likelihood of a link and sets a default outer deadline of 15 days after the provider, or where applicable the deployer, becomes aware of the serious incident. Shorter outer deadlines apply for two categories: a widespread infringement or a serious and irreversible disruption of critical infrastructure management or operation must be reported immediately and no later than two days after awareness, and a death-related incident must be reported immediately after a causal relationship is established or suspected and no later than 10 days after awareness.

If a complete report would delay timely reporting, Article 73 allows an incomplete initial report followed by a complete report. After reporting, the provider must without delay investigate the serious incident and the AI system concerned, including a risk assessment and corrective action, and must cooperate with competent authorities and, where relevant, the notified body.

  • Keep separate timestamps for awareness, causal-link or reasonable-likelihood assessment, initial report, complete report, authority acknowledgements, and corrective actions.
  • Escalate critical-infrastructure disruption, widespread-infringement, and death-related cases into the shorter Article 73 timing track instead of using the default timing.
  • Do not alter the AI system in a way that may affect later evaluation of incident causes before informing competent authorities of that action.
  • Link the Article 73 report to the provider quality-management procedure for serious incidents and to the post-market monitoring evidence for the affected high-risk AI system.

Can a provider submit an incomplete EU AI Act Article 73 serious-incident report?

Yes. Article 73 allows an initial incomplete report when necessary to ensure timely reporting, followed by a complete report. The incomplete report should not be treated as closure; the provider still needs the investigation, risk assessment, corrective-action record, and authority cooperation required after reporting.

What corrective-action evidence matters after an EU AI Act serious-incident report?

The provider should preserve the incident facts, causal-link analysis, risk assessment, corrective actions, authority communications, notified-body communications where relevant, and any decision not to alter the AI system before notifying competent authorities. Article 20 also requires providers that consider or have reason to consider their high-risk AI system is non-conforming to take corrective actions such as bringing it into conformity, withdrawing it, disabling it, or recalling it as appropriate.

Citations
EU AI Act Article 73 serious incident

How should deployers, importers, distributors, and GPAI model providers be separated?

A deployer is not the normal Article 73 reporter, but it has an explicit escalation duty when it identifies a serious incident: inform the provider first, then the importer or distributor and the relevant market surveillance authorities. Importers and distributors have their own high-risk AI system duties to withhold, notify, or help correct non-conforming or risky systems, so incident intake should route them into the communication record even when the provider owns the Article 73 report.

From 27 July 2026, the AI Office has exclusive supervision over specified AI systems. The covered set includes certain systems based on a general-purpose AI model where the model and system share the same provider or undertaking, subject to the listed exclusions for product-related systems, critical infrastructure, systems provided by law-enforcement or border-management authorities, financial-institution systems within Article 74(6), and justice systems, plus systems that constitute or are integrated into a designated very large online platform or very large online search engine. Providers in that set report Article 73 incidents to the AI Office, which transmits the relevant information to the national market surveillance authority.

Do not merge this system-level route with the EU AI Act rule for providers of general-purpose AI models with systemic risk. Article 55 requires those model providers to keep track of, document, and report without undue delay to the AI Office and, as appropriate, national competent authorities relevant information about serious incidents and possible corrective measures. The Commission's GPAI serious-incident template is for that Article 55 model-provider context, not a replacement for an Article 73 high-risk AI system report.

  • Check whether an importer, distributor, deployer, or other third party has become the provider by putting its name or trademark on the high-risk AI system, making a substantial modification, or changing intended purpose so the system becomes high-risk.
  • Use Article 23 importer records for provider, authorised-representative, and market surveillance authority notice when the importer has sufficient reason to consider the high-risk AI system is non-conforming, falsified, or risky.
  • Use Article 24 distributor records for provider or importer notice, authority notice, and corrective-action handling when the distributor has sufficient reason to consider a high-risk AI system it made available is non-conforming or risky.
  • Check amended Article 75 before selecting the recipient. Record whether the system is under the AI Office's exclusive competence, which inclusion or exclusion applies, and whether the report went to the AI Office or the Member State authorities where the incident occurred.
  • Use a separate Article 55 record when the incident concerns a general-purpose AI model with systemic risk, including the model involved, resulting harm, chain of events, evidence of model involvement, response, root-cause analysis, and any corrective measures.

Should GPAI systemic-risk serious incidents be reported through the same EU AI Act Article 73 process?

No. Article 73 is for providers of high-risk AI systems. Providers of general-purpose AI models with systemic risk have a separate Article 55 duty to keep track of, document, and report without undue delay to the AI Office and, as appropriate, national competent authorities relevant information about serious incidents and possible corrective measures.

Why should importers and distributors be included in an EU AI Act serious-incident workflow?

They may not own the provider's Article 73 report, but Articles 23 and 24 require them to act on information that a high-risk AI system is non-conforming or presents a risk. Distributors may need to take or ensure corrective actions, and both importers and distributors may need to notify the provider, other operators, and competent authorities depending on their role and the facts.

When does a high-risk AI system provider report an Article 73 incident to the AI Office?

From 27 July 2026, amended Article 75(1a) routes the report to the AI Office when the AI Office has exclusive competence over the system under Article 75(1). This includes specified systems based on a general-purpose AI model where the model and system share a provider or undertaking, subject to the listed exclusions, and systems that constitute or are integrated into a designated very large online platform or very large online search engine. The provider should document the exact inclusion or exclusion instead of routing by product label alone.

Citations
EU AI Act FRIA FAQ: Article 27 Scope, Contents, and Notification

When does Article 27 require a FRIA?

Article 27 requires the assessment before deployment of a high-risk AI system referred to in Article 6(2), which points to the Annex III high-risk areas. The rule expressly excludes high-risk AI systems intended to be used in the area listed in point 2 of Annex III, the critical-infrastructure area.

The trigger then depends on the deployer. A FRIA is required for deployers that are bodies governed by public law, private entities providing public services, and deployers of high-risk systems in Annex III points 5(b) and 5(c), which cover creditworthiness or credit scoring and risk assessment or pricing for life and health insurance.

The duty applies to the first use. A deployer may rely on a previous FRIA or an existing provider assessment in a similar case, but it remains responsible for checking that the system, process, affected groups, risks, oversight, and mitigations match its own deployment. If a required element changes or becomes outdated during use, the deployer must update the information.

  • Start with Article 6(2): confirm that the system is an Annex III high-risk AI system.
  • Check the carve-out: Annex III point 2 critical-infrastructure systems are excluded from Article 27 FRIA, even though they may still be high-risk and are registered at national level under Article 49(5).
  • Check the deployer category: public-law bodies, private entities providing public services, and deployers using Annex III point 5(b) or 5(c) systems are the Article 27 categories.
  • Do not treat a provider's high-risk classification memo as a FRIA; Article 27 is a deployer-side assessment of the specific use.
  • After completing the FRIA, notify the market surveillance authority of the results by submitting the completed Article 27 template, unless the Article 46(1) exemption from notification applies.

Does every EU AI Act high-risk system need a FRIA?

No. Article 27 applies to specified deployers before deploying Article 6(2) Annex III high-risk systems, with an express exception for the Annex III point 2 critical-infrastructure area. Product-safety high-risk systems classified under Article 6(1), and Annex III systems outside the named deployer categories, should still be assessed for other AI Act duties, but Article 27 is not automatically triggered by the high-risk label alone.

Which deployers are named in Article 27?

Article 27 names deployers that are bodies governed by public law, private entities providing public services, and deployers of high-risk systems referred to in Annex III points 5(b) and 5(c). Recital 96 explains that private public-service examples can be linked to public-interest tasks such as education, healthcare, social services, housing, and administration of justice.

What happens to critical-infrastructure AI systems under Annex III point 2?

Article 27 excludes high-risk AI systems intended for the Annex III point 2 critical-infrastructure area from the FRIA duty. That does not remove all AI Act obligations: Annex III point 2 covers safety components in critical digital infrastructure, road traffic, and water, gas, heating, or electricity supply, and Article 49(5) says those high-risk systems are registered at national level.

When does the EU AI Act FRIA duty start to apply?

Regulation (EU) 2026/1744, published on 24 July 2026 and entering into force on 27 July 2026, moves Chapter III Sections 1 to 3 to 2 December 2027 for Article 6(2) Annex III high-risk systems. Because Article 27 covers specified Annex III deployments, that is the relevant application date. Public-authority systems already on the market or in service have a separate Article 111 deadline of 2 August 2030, while other legacy systems depend on whether their design changes significantly after the applicable date.

Citations
EU AI Act FRIA FAQ: Article 27 Scope, Contents, and Notification

What must the FRIA contain?

Article 27 gives a concrete assessment list. The record should describe the deployer's process in which the high-risk AI system will be used, the intended period and frequency of use, the categories of natural persons and groups likely to be affected, and the specific risks of harm for those groups.

The FRIA also needs the human oversight implementation described according to the instructions for use, plus the measures to take if the risks materialise. Those measures include internal governance and complaint mechanisms, so the evidence should reach beyond legal sign-off into operating procedures.

  • Process evidence: workflow map, intended purpose, provider instructions for use, and the deployer's use case.
  • Use evidence: expected start, duration or period of use, frequency, countries or operating units, and whether this is a first use or a similar case relying on an earlier assessment.
  • Affected-person evidence: natural-person categories, affected groups, dependency or vulnerability factors, and the decision or service the AI output influences.
  • Risk evidence: specific fundamental-rights harms, provider Article 13 information considered, residual risks, and escalation criteria.
  • Control evidence: human oversight procedure, complaint route, internal governance owner, operational playbook for risk materialisation, and approval record.

Can a deployer reuse an earlier FRIA?

Yes, but only in similar cases. Article 27 says the obligation applies to the first use of the high-risk AI system and that a deployer may rely on previous FRIAs or existing impact assessments in similar cases. The record should explain why the earlier assessment is similar enough for the current process, affected groups, risks, oversight, and complaint arrangements.

When must the FRIA be updated?

Article 27 requires an update when, during use, the deployer considers that any assessment element has changed or is no longer up to date. Practical update triggers include a changed deployment process, materially different use frequency, a new affected group, changed provider instructions, new risk evidence, or changed oversight, governance, or complaint mechanisms.

What practical proof should an Article 27 FRIA file contain?

Keep the classification decision, the deployer-category check, the Annex III point check, provider instructions used for the risk analysis, the Article 27 assessment answers, evidence of human oversight and complaint routing, the market-surveillance notification record, and, where applicable, the DPIA link and EU database or national registration evidence.

Citations
EU AI Act FRIA FAQ: Article 27 Scope, Contents, and Notification

How does FRIA connect to DPIA, notification, and registration?

A FRIA does not replace a GDPR or law-enforcement data protection impact assessment. From 27 July 2026, amended Article 27(4) lets a deployer cross-reference the relevant parts of a DPIA under GDPR Article 35 or Directive (EU) 2016/680 Article 27, or include those parts in the FRIA, when they already meet an Article 27 obligation. The deployer must still complete every Article 27 element that the DPIA does not cover.

After performing the FRIA, the deployer must notify the market surveillance authority of the results by submitting the filled-out template referred to in Article 27. Separately, Article 49 requires public authorities, Union bodies, agencies, offices, or persons acting on their behalf to register their use of Annex III high-risk systems in the EU database, except Annex III point 2 systems, which are registered nationally.

  • Map the DPIA and FRIA where personal-data risk and fundamental-rights risk overlap. Cross-reference or include the DPIA sections that meet Article 27 elements, then complete the remaining FRIA fields.
  • Keep the market-surveillance authority notification proof with the completed Article 27 template once the FRIA is performed.
  • For public-authority deployers, confirm Article 49 registration before putting the Annex III high-risk system into service or use.
  • For law enforcement, migration, asylum, and border-control Annex III systems, expect restricted EU database registration rules under Article 49(4).
  • For Annex III point 2 critical-infrastructure systems, route registration evidence to the national-level process described in Article 49(5).

Does completing a DPIA satisfy Article 27?

Not by itself. Under Article 27(4), as replaced by Regulation (EU) 2026/1744 from 27 July 2026, the deployer may cross-reference relevant DPIA sections or include them in the FRIA when they already meet an Article 27 obligation. The deployer must still add any missing process, affected-group, fundamental-rights risk, human-oversight, governance, complaint, notification, and AI Act registration evidence.

Who receives the FRIA results?

Article 27 says the deployer must notify the market surveillance authority of the FRIA results after the assessment is performed, using the filled-out template referred to in Article 27. The page should not assume a single authority name for every Member State; route the notification to the applicable market surveillance authority once identified for the deployment.

What should a reviewer check before approving first use?

Check that the system is an Article 6(2) Annex III high-risk system, the Annex III point 2 exclusion has been considered, the deployer category is documented, the Article 27 assessment fields are complete, the DPIA relationship is mapped where applicable, notification evidence is ready, and Article 49 registration evidence is present where the deployer is a public authority or acting on one.

Citations
EU AI Act GPAI and Systemic-Risk Duties: Article 53 and 55

What does Article 53 require from GPAI model providers?

Article 53 requires providers of general-purpose AI models to keep technical documentation for authorities, provide information to downstream AI system providers, maintain a copyright-compliance policy, and publish a sufficiently detailed summary of the content used for training.

The downstream information must help AI system providers understand the model's capabilities and limitations and comply with their own AI Act obligations, while protecting intellectual property, confidential business information, and trade secrets.

  • Keep model technical documentation up to date, including the training and testing process and evaluation results, for the AI Office and national competent authorities on request.
  • Provide integration documentation to downstream providers, including capabilities, limitations, acceptable use policies, release and distribution details, architecture, software dependencies, and other Annex XII information.
  • Put in place a policy to comply with Union copyright and related-rights law, including rights reservations under Article 4(3) of Directive (EU) 2019/790.
  • Publish the Article 53(1)(d) public summary of training content using the AI Office template.

What makes a model a general-purpose AI model under the EU AI Act?

A general-purpose AI model is an AI model, including one trained with large amounts of data using self-supervision at scale, that has significant generality, can competently perform a wide range of distinct tasks, and can be integrated into many downstream systems or applications. The definition excludes models used for research, development, or prototyping before they are placed on the market.

Does Article 53 apply only to GPAI models with systemic risk?

No. Article 53 is the baseline duty for providers of general-purpose AI models. Systemic-risk status adds Article 55 duties, but it does not supersede Article 53.

What should downstream providers receive for EU AI Act GPAI integration?

They should receive enough current documentation to understand the GPAI model's tasks, capabilities, limitations, acceptable use policies, release method, input and output modalities, relevant software, architecture, parameters, and integration constraints so they can meet their own AI Act obligations.

Citations
EU AI Act GPAI and Systemic-Risk Duties: Article 53 and 55

When is a GPAI model classified as having systemic risk?

Article 51 classifies a general-purpose AI model as a GPAI model with systemic risk if it has high-impact capabilities, or if the Commission designates it after an ex officio assessment or a qualified alert from the scientific panel using Annex XIII criteria.

The Act creates a compute-based presumption: a GPAI model is presumed to have high-impact capabilities when the cumulative computation used for training is greater than 10^25 floating point operations. Article 52 then requires notification to the Commission without delay and in any event within two weeks after the requirement is met or it becomes known that it will be met. The Commission can also designate a model under the separate Annex XIII route.

Systemic-risk analysis concerns Union-level effects from the model's reach or high-impact capabilities. The Regulation names actual or reasonably foreseeable negative effects on public health and safety, public security, fundamental rights, or society as a whole, including propagation across the value chain. The provider should assess plausible downstream effects and misuse across sectors alongside benchmark performance and direct applications.

  • Record the model's training compute estimate, methodology, and supporting evidence before market placement decisions.
  • Escalate if training compute exceeds 10^25 FLOP or if model reach, modalities, autonomy, scalability, tools, user base, or training data suggest Annex XIII significance.
  • If relying on the Article 52 exception argument, keep objective evidence for why the model does not present systemic risk despite meeting the high-impact presumption.
  • Track Commission designation and reassessment decisions because systemic-risk status changes the provider duty set.

Is 10^25 FLOP the only EU AI Act systemic-risk route for GPAI models?

No. The 10^25 FLOP threshold creates a presumption of high-impact capabilities, but the Commission can also designate a GPAI model as systemic risk based on Annex XIII criteria, including capability or impact considerations.

Can a provider contest systemic-risk classification under the EU AI Act?

Yes. Article 52 allows a provider that meets the high-impact condition to submit sufficiently substantiated arguments that, exceptionally, the model does not present systemic risk due to its specific characteristics. A provider designated by Commission decision can also request reassessment with objective, detailed, and new reasons.

Citations
EU AI Act GPAI and Systemic-Risk Duties: Article 53 and 55

What extra duties apply under Article 55 for GPAI models with systemic risk?

Article 55 duties apply in addition to Articles 53 and 54. Providers of GPAI models with systemic risk must evaluate the model with state-of-the-art protocols and tools, conduct and document adversarial testing, assess and mitigate systemic risks at Union level, track and report serious incidents, and protect the model and its physical infrastructure with adequate cybersecurity.

The Article 55 work should be continuous across development, placing on the market, and use. It should cover sources of systemic risk, post-market learning from incidents and misuse, corrective measures, and security risks such as model leakage, unauthorised releases, circumvention of safety measures, unauthorised access, and model theft.

  • Model evaluation file: protocols, benchmarks or other methodologies, evaluation criteria, metrics, results, known limitations, and who performed the evaluation.
  • Adversarial testing file: internal or external testing plan, test scope, model adaptations, red-team findings, mitigation decisions, and unresolved risk rationale.
  • Systemic-risk file: Union-level risk sources, affected public interests, likelihood and severity, mitigation measures, residual risk, and post-market monitoring triggers.
  • Serious-incident file: incident facts, model version, affected use or integration, known or likely harm, corrective measures, reporting route to the AI Office and, where appropriate, national competent authorities.
  • Cybersecurity file: controls for weights, algorithms, servers, datasets, access management, physical security, leak prevention, vulnerability handling, and attack response.

What serious incidents must systemic-risk GPAI providers report under Article 55?

Article 55 requires providers to keep track of, document, and report without undue delay relevant information about serious incidents and possible corrective measures to the AI Office and, as appropriate, national competent authorities. The Commission has published a template for serious incidents involving GPAI models with systemic risk.

Does Article 55 cybersecurity cover only the API or app built around the model?

No. Article 55 refers to cybersecurity protection for the GPAI model with systemic risk and the physical infrastructure of the model. Recital 115 specifically points to model weights, algorithms, servers, datasets, operational security, cybersecurity policies, technical controls, and cyber and physical access controls.

Citations
EU AI Act GPAI and Systemic-Risk Duties: Article 53 and 55

How do copyright policy, training summaries, open-source models, and the Code of Practice fit together?

The Article 53 copyright policy and public training-content summary are separate duties. The copyright policy is an internal compliance policy for Union copyright and related-rights law. The public summary is a transparency artifact about the content used for model training, published according to the AI Office template.

Open-source status can remove only the Article 53(1)(a) and (b) documentation and downstream-information duties when the licence and public-availability conditions in Article 53(2) are met. It does not remove the copyright-policy or public training-summary duties, and the exception does not apply to GPAI models with systemic risk.

  • Copyright policy: identify and comply with rights reservations under Article 4(3) of Directive (EU) 2019/790, including through state-of-the-art technologies where relevant.
  • Training-content summary: publish a sufficiently detailed summary using the AI Office template, generally comprehensive in scope while protecting trade secrets and confidential business information.
  • Open-source caveat: Article 53(2) excludes only Article 53(1)(a) and (b) for qualifying open-source GPAI models, and not for GPAI models with systemic risk.
  • Code of Practice caveat: providers may rely on approved codes of practice to demonstrate compliance until harmonised standards are published, but providers outside an approved code or standard must show alternative adequate means to the Commission.
  • Copyright Code caveat: the GPAI Copyright Chapter helps demonstrate Article 53(1)(c) implementation, but it does not itself decide compliance with Union copyright law.

Does publishing model weights remove the EU AI Act training-summary duty?

No. The AI Act and Commission materials distinguish open model access from transparency about training content. The public training-content summary and copyright policy remain relevant even for qualifying open-source GPAI models.

Can a GPAI provider use the Code of Practice instead of Article 53 or Article 55?

No. The Code of Practice is a way to demonstrate compliance with covered obligations until harmonised standards are published. It is not a replacement for the underlying AI Act duties, and providers that do not use an approved code or standard must demonstrate alternative adequate means of compliance.

Citations
EU AI Act GPAI and Systemic-Risk Duties: Article 53 and 55

What staged application and enforcement points are supported for GPAI duties?

The Commission guidelines state that Chapter V obligations for GPAI model providers apply from 2 August 2025. They also state that Commission enforcement powers for these obligations enter into application on 2 August 2026, and that providers of GPAI models placed on the market before 2 August 2025 must take necessary compliance steps by 2 August 2027.

The same guidance says the guidelines are not legally binding and that authoritative interpretation of the AI Act is for the Court of Justice of the European Union. Treat the dates above as implementation milestones based on the cited Commission guidance, not as a complete enforcement calendar for every AI Act duty.

  • From 2 August 2025: Chapter V GPAI provider obligations enter into application according to the Commission guidelines.
  • From 2 August 2026: the Commission says its enforcement powers for GPAI provider obligations enter into application, including fines under Article 101.
  • By 2 August 2027: providers of GPAI models placed on the market before 2 August 2025 must take necessary steps to comply, according to the guidelines and Article 111(3) reference.
  • Do not use this GPAI FAQ to infer deadlines for unrelated high-risk AI system, prohibited-practice, transparency, product-law, or national-authority obligations.

Who enforces EU AI Act duties for GPAI model providers?

The Commission enforces compliance with GPAI model provider obligations, including through the AI Office, which monitors and supports compliance with general-purpose AI rules. The Commission guidelines also note that providers should cooperate with the AI Office and national competent authorities.

Are the Commission GPAI guidelines legally binding?

No. The guidelines state that they are not binding and that authoritative interpretation of the AI Act may only be given by the Court of Justice of the European Union. They still set out the Commission's interpretation and application approach for enforcement.

Citations
EU AI Act post-market monitoring FAQ for high-risk AI systems

What does Article 72 require for EU AI Act post-market monitoring?

Article 72 requires providers of high-risk AI systems to establish and document a post-market monitoring system that is proportionate to the AI technologies and risks of the system. The system must actively and systematically collect, document, and analyse relevant data on the high-risk AI system's performance throughout its lifetime.

The monitoring system must be based on a post-market monitoring plan that forms part of the Annex IV technical documentation. Regulation (EU) 2026/1744, published on 24 July 2026 and entering into force on 27 July 2026, replaces the earlier implementing-act mechanism with Commission guidance, including a template, due by 2 September 2027. Until that guidance is available, an internal or vendor form can organise evidence but should not be presented as the Commission template.

For high-risk systems already covered by Section A of Annex I product legislation, Article 72 allows the provider to integrate equivalent AI Act elements into an existing sectoral post-market system and plan. The same integration option applies to Annex III point 5 systems placed on the market or put into service by financial institutions subject to Union financial-services governance rules.

  • Define the monitored high-risk AI system, intended purpose, deployed versions, integrations, and known interaction points with other AI systems.
  • Specify which performance, safety, fundamental-rights, robustness, cybersecurity, anomaly, complaint, and incident signals are collected after deployment.
  • Explain how deployer feedback and other external sources are triaged, documented, analysed, and fed into risk management and technical documentation updates.
  • Link monitoring outputs to Article 20 corrective action and Article 73 serious-incident reporting so risk signals do not stop at product support.
  • Keep the monitoring plan with the technical documentation and update the lifecycle change record when provider-made changes affect the system.

How should teams handle post-market monitoring under the EU AI Act?

For a high-risk AI system, treat post-market monitoring as a provider-owned Article 72 control. The provider should maintain a documented monitoring system and plan, collect and analyse relevant lifetime performance data, use deployer feedback where relevant, assess continued compliance with Chapter III Section 2 requirements, and route confirmed risk signals into corrective action or serious-incident reporting when the facts meet those triggers.

When does Article 72 post-market monitoring apply?

Article 72 remains on the AI Act's general application date of 2 August 2026. Regulation (EU) 2026/1744 separately moves Chapter III Sections 1 to 3 to 2 December 2027 for Annex III high-risk systems and 2 August 2028 for Annex I high-risk systems. Providers should record which provisions apply to the specific system and date instead of treating every high-risk obligation as having one start date.

Citations
EU AI Act post-market monitoring FAQ for high-risk AI systems

How should deployer feedback, serious incidents, logs, and corrective action connect?

Deployers are not the Article 72 plan owner, but Article 26 makes them important monitoring inputs. Deployers must monitor high-risk AI systems on the basis of the instructions for use and, where relevant, inform providers under Article 72.

If a deployer has reason to consider that use in accordance with the instructions may present a risk under Article 79(1), the deployer must inform the provider or distributor and the relevant market surveillance authority without undue delay and suspend use. If the deployer identifies a serious incident, it must immediately inform the provider first, then the importer or distributor and the relevant market surveillance authorities; if the provider cannot be reached, Article 73 applies mutatis mutandis.

Provider handling should therefore separate ordinary performance feedback from nonconformity, risk, and serious-incident paths. Article 20 requires providers that consider or have reason to consider their high-risk AI system is not in conformity to immediately take corrective action to bring it into conformity, withdraw it, disable it, or recall it as appropriate.

  • Deployer feedback intake: capture the system, version, use context, instruction-for-use step, observed output, affected persons or groups, operator action, and available logs.
  • Risk escalation: if the deployer reports an Article 79(1)-type risk, record the suspension status, market-surveillance authority notice, and provider response owner.
  • Serious-incident escalation: link the record to Article 73 reporting analysis, causal-link assessment, authority routing, investigation, risk assessment, and corrective action.
  • Corrective action: document whether the provider brought the system into conformity, disabled it, withdrew it, recalled it, or informed distributors, deployers, authorised representatives, or importers.
  • Log handling: use Article 12 and Article 19 provider logs and Article 26 deployer-controlled logs to reconstruct the event, but check privacy, sector, and law-enforcement limits before requesting or transferring data.
Citations
EU AI Act post-market monitoring FAQ for high-risk AI systems

What evidence should a high-risk AI provider keep for Article 72?

The evidence should show systematic continuing-compliance review as well as incident logging. Keep the plan, monitored signals, analysis records, outcomes, and technical-documentation updates together so a reviewer can trace why a risk signal did or did not trigger corrective action, a conformity update, or a serious-incident report.

Annex IV also expects technical documentation to describe relevant lifecycle changes and the post-market performance-evaluation system, including the Article 72 monitoring plan. That makes change history part of the post-market monitoring evidence set.

  • Post-market monitoring plan: scope, data sources, deployer-feedback channels, signal taxonomy, analysis cadence, escalation paths, and responsible roles.
  • Signal records: complaints, anomalies, performance drift, bias or discrimination indicators, cybersecurity issues, human-oversight failures, misuse patterns, and interaction issues with other AI systems.
  • Log evidence: provider-controlled automatically generated logs, deployer-controlled logs when shared lawfully, retention basis, access controls, and integrity checks.
  • Decision records: root-cause analysis, continued-compliance assessment, serious-incident determination, corrective-action decision, and authority communication status.
  • Lifecycle records: versions, configuration changes, model or data changes, intended-purpose changes, integration changes, and any substantial-modification or new conformity-assessment trigger considered.
Citations
EU AI Act post-market monitoring FAQ for high-risk AI systems

Which changes should reopen the post-market monitoring review?

Reopen the Article 72 review when the real-world system no longer matches the monitoring plan, instructions for use, technical documentation, or risk-management assumptions. The strongest triggers are changes that affect intended purpose, high-risk classification, performance, affected groups, human oversight, logs, integration context, or risk controls.

A distributor, importer, deployer, or other third party can become the provider for a high-risk AI system if it puts its name or trademark on the system, makes a substantial modification while the system remains high-risk, or modifies the intended purpose of a non-high-risk AI system so it becomes high-risk. Those lifecycle changes should not be treated as ordinary backlog items.

  • New or changed intended purpose, user population, deployment context, country rollout, or affected group.
  • Substantial modification to a high-risk AI system after placement on the market or putting into service.
  • Integration with another AI system, model, data source, workflow, or product that changes performance or risk assumptions.
  • Observed performance drift, repeated anomalies, serious-incident indicators, or unresolved deployer feedback.
  • Changes to logs, human oversight, instructions for use, cybersecurity controls, or maintenance processes that affect traceability or safe operation.
Citations
Regulation (EU) 2024/1689 (EU AI Act)

Primary legal text for Article 25 value-chain responsibility changes, Article 43 substantial-modification conformity assessment, and Annex IV lifecycle-change documentation.

EU AI Act provider vs deployer role boundaries: Article 3 and Article 25

What is the core provider-versus-deployer test under Article 3 of the EU AI Act?

A provider is the actor that develops an AI system or general-purpose AI model, or has one developed, and places it on the market or puts the AI system into service under its own name or trademark. That test is about development control, commissioning, market placement, service launch, and branding, not only technical authorship.

A deployer is the actor using an AI system under its authority, except for personal non-professional use. A company can therefore be a deployer of a supplier system even when the supplier remains the provider, because the company controls the concrete use context, users, operating process, input data under its control, and internal oversight.

  • Treat name, trademark, market-placement records, commissioning contracts, technical documentation, and launch materials as provider evidence.
  • Treat business-process ownership, user instructions, access controls, input-data procedures, monitoring records, and logs under the organisation's control as deployer evidence.
  • Do not use 'owner' as a substitute role. The AI Act uses defined actors such as provider, deployer, importer, distributor, authorised representative, product manufacturer, and operator.
  • Classify each system and model separately. A party can be the deployer of one AI system, the provider of a modified high-risk system, and a downstream provider integrating a GPAI model in another product.

Can one organisation be both provider and deployer under the EU AI Act?

Yes. Article 3 definitions do not make the roles mutually exclusive. For example, an organisation that develops and puts an AI system into service under its own name can be the provider, while the same organisation also uses that system internally under its authority as deployer. The evidence should identify which obligations are being met in which capacity.

Is a purchaser automatically only a deployer under the EU AI Act?

No. A purchaser that simply uses a supplier's AI system under its authority is normally analysed as a deployer for that use, but Article 25 can make a deployer the provider of a high-risk AI system if it rebrands the system, substantially modifies it, or changes the intended purpose so that the system becomes high-risk.

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