Search every question across sub-FAQs

The AI Act uses 'operator' as an umbrella term that includes provider, product manufacturer, deployer, authorised representative, importer, and distributor. It is useful for scoping the full value chain, but it is not enough for assigning concrete duties because the named roles have different triggers.

An authorised representative is a Union-based person with a written mandate from a provider to carry out obligations and procedures on the provider's behalf. An importer places on the Union market an AI system bearing the name or trademark of a third-country person. A distributor is a supply-chain actor, other than provider or importer, that makes an AI system available on the Union market.

A product manufacturer is treated as the provider of a high-risk AI system that is a safety component of a product covered by the Union harmonisation legislation in Section A of Annex I when the system is placed on the market together with the product under the manufacturer's name or trademark, or is put into service under that name or trademark after the product has been placed on the market.

Article 25 is the role-shift rule for high-risk AI systems. A distributor, importer, deployer, or other third party is treated as the provider, and is subject to provider obligations, when one of three triggers is met: it puts its name or trademark on an already placed or put-into-service high-risk AI system; it makes a substantial modification to an already placed or put-into-service high-risk AI system so that it remains high-risk; or it changes the intended purpose of an already placed or put-into-service AI system, including a GPAI system, so that the system becomes high-risk.

When an Article 25 shift occurs, the initial provider is no longer considered the provider of that specific AI system for AI Act purposes, but must closely cooperate with the new provider and provide necessary information, technical access, and other reasonably expected assistance. That cooperation rule does not apply where the initial provider clearly specified that its AI system must not be changed into a high-risk system.

From 27 July 2026, amended Article 25 specifies that this cooperation includes, where relevant, technical documentation sufficient to assess Article 16 compliance, known limitations and failure modes, and targeted technical access for testing and validation.

A contract can allocate work, access, indemnities, and cooperation, but it does not erase a statutory role created by the facts. Amended Article 25(4) also requires the high-risk system provider and a third party supplying an integrated AI system, model, tool, service, component, or process to specify the needed information, capabilities, technical access, and assistance in a written agreement. The paragraph excludes publicly accessible free and open-source tools, services, processes, or components other than general-purpose AI models.

A GPAI model provider is not automatically the provider of every AI system that later integrates the model. The legal text defines a general-purpose AI model separately, and Annex XII requires transparency information for downstream providers that integrate the model into their AI systems.

Commission GPAI guidance gives practical examples: the actor that develops and places a GPAI model on the Union market is the provider; an actor that has a model developed on its behalf and places it on the market is the provider; and a downstream actor integrating a GPAI model into an AI system may be the provider of that AI system.

For downstream modifications, the Commission guidance says not every modification makes the modifier a GPAI model provider. The modifier becomes the provider of the modified GPAI model only where the modification leads to a significant change in the model's generality, capabilities, or systemic risk, with the guidance giving an indicative training-compute criterion for that assessment.

The evidence should prove the legal role, the factual trigger, and the boundary of responsibility. Avoid one generic AI owner record. Instead, keep a role matrix for each AI system and GPAI model version, because the same supplier relationship can involve several actors at different layers of the value chain.

For deployer duties, preserve records showing use according to instructions, human oversight assignment, monitoring based on instructions for use, incident escalation to provider/importer/distributor and authorities where relevant, logs under deployer control, worker information where workplace use is involved, and any required fundamental-rights impact assessment for covered high-risk deployments.

For a high-risk AI system, Article 11 makes technical documentation a pre-market or pre-service requirement. The file must be drawn up before the system is placed on the market or put into service, kept up to date, and written to demonstrate compliance with the high-risk requirements in Chapter III, Section 2.

The documentation should let a national competent authority or notified body understand the system without reverse-engineering the product. A usable file therefore starts with system identity and intended purpose, then shows how design, data, testing, risk controls, human oversight, cybersecurity, conformity, and post-market monitoring support that intended purpose.

Article 11 applies the Annex IV content as relevant to the system. It does not excuse a missing item without analysis: mark an item not applicable only when the system facts support that conclusion, and keep the reason in the controlled file.

Treat Annex IV as a technical-file table of contents. The first section identifies what the system is and how it is supplied. The second section explains how it was built. Later sections show how it is monitored, controlled, tested, changed, and assessed against the AI Act requirements.

The strongest documentation is traceable: every claim about system purpose, data, model behavior, oversight, cybersecurity, performance, and residual risk points to a controlled artifact such as a requirements record, architecture diagram, dataset sheet, test report, risk-control register, release note, user instruction, or conformity file.

For a high-risk system supplied by a third party, the provider still owns the Article 11 file. Supplier documentation can support it, but the provider must connect third-party components and pre-trained systems to the final system's intended purpose, integration choices, tests, limitations, and risk controls.

Annex IV does not stop at design-time evidence. It asks for the harmonised standards applied in full or in part when their references have been published in the Official Journal of the European Union. If no such harmonised standards have been applied, the file must describe the solutions adopted to meet the high-risk requirements and list other relevant standards and technical specifications applied.

The same file should include a copy of the EU declaration of conformity and a detailed description of the post-market system used to evaluate performance. Article 72 makes the post-market monitoring plan part of the Annex IV technical documentation.

Article 18 requires the provider to keep the technical documentation, quality-management documentation, notified-body records where applicable, and EU declaration of conformity available to national competent authorities for 10 years after the high-risk system is placed on the market or put into service. That retention rule is separate from the minimum six-month rule for automatically generated logs under Articles 19 and 26.

Article 43 uses different routes for different high-risk AI systems. For high-risk systems listed in point 1 of Annex III, a provider that demonstrates compliance by applying the relevant harmonised standards under Article 40 or, where applicable, common specifications under Article 41 may choose Annex VI internal control or Annex VII notified-body assessment.

Annex III point 1 is the biometrics category. It covers specified remote biometric identification systems, biometric categorisation systems using sensitive or protected characteristics or inferred attributes, and emotion recognition systems, subject to the precise Annex III wording and exclusions. It should not be confused with every system that processes a face, voice, or other biometric data.

For that same Annex III point 1 category, Annex VII notified-body assessment is required when harmonised standards and common specifications are not available, when the provider has not applied the relevant harmonised standard or has applied only part of it, when available common specifications have not been applied, or when a harmonised standard has been published with a restriction for the restricted part.

For high-risk AI systems in points 2 to 8 of Annex III, Article 43 says providers follow Annex VI internal control, with no notified-body involvement.

For high-risk AI systems covered by Union harmonisation legislation in Section A of Annex I, Article 43(3), as replaced by Regulation (EU) 2026/1744 from 27 July 2026, keeps the conformity route under the applicable product law and makes the AI Act Section 2 requirements part of that assessment. If that product law permits assessment without a third party when all relevant harmonised standards are applied, inclusion of a high-risk AI safety component does not by itself force third-party assessment. If the same system is also listed in Annex III, the product-law route controls.

Annex VI internal control is still a formal conformity assessment. The provider verifies that its quality management system complies with Article 17, examines the technical documentation to assess compliance with Chapter III Section 2 requirements, and verifies that design, development, and post-market monitoring are consistent with the technical documentation.

The evidence should therefore be more than a checklist. Article 11 requires technical documentation to be drawn up before placing the high-risk AI system on the market or putting it into service, kept up to date, and written so competent authorities and notified bodies can assess compliance. Annex IV lists expected content, including intended purpose, system versions, development methods, data requirements, human oversight, validation and testing, cybersecurity, risk management, standards used, the EU declaration of conformity, and post-market monitoring.

Annex VII adds notified-body review of both the provider's quality management system and the technical documentation for the AI system. The provider's application includes provider identity, the AI systems covered by the same quality management system, technical documentation for each system, quality-management documentation covering Article 17, procedures to keep the system adequate and effective, and a declaration that the same application was not lodged with another notified body.

The notified body examines whether the quality management system satisfies Article 17 and examines the technical documentation. Where needed, it may require further evidence or tests, carry out tests itself, and, after other reasonable means are insufficient, request access to training and trained models subject to applicable protection for intellectual property and trade secrets. If the system conforms, the notified body issues a Union technical documentation assessment certificate; if not, it refuses and gives reasons.

After approval, Annex VII creates an ongoing change and surveillance track. Intended changes to the approved quality management system, the covered system list, or an AI system change that could affect compliance or intended purpose must be brought to the notified body. The notified body carries out surveillance of the approved quality management system, including periodic audits.

The conformity assessment route should close into release evidence. Article 47 requires the provider to draw up a written, machine-readable, physical, or electronically signed EU declaration of conformity for each high-risk AI system, keep it available to national competent authorities for 10 years, identify the system, state conformity with the Section 2 requirements, include Annex V information, translate it for relevant national competent authorities, and keep it up to date.

Article 48 requires CE marking for high-risk AI systems. For digital high-risk AI systems, a digital CE marking can be used only when it is easily accessible through the system interface or through an accessible machine-readable code or other electronic means. Where a notified body was responsible for the Article 43 conformity assessment, its identification number follows the CE marking and is also indicated in promotional material that mentions CE conformity.

Article 49 registration is separate from CE marking and must be checked before release. Providers or authorised representatives register themselves and Annex III high-risk AI systems in the EU database before placing them on the market or putting them into service, except for point 2 of Annex III, which is registered at national level. Providers also register systems they concluded are not high risk under Article 6(3). Public authorities, Union institutions, bodies, offices, agencies, and persons acting on their behalf have deployer registration duties for covered Annex III systems before use.

Article 46 creates a narrow, time-limited derogation from completing conformity assessment before placement or use. A market surveillance authority may authorise a specific high-risk system for exceptional public-security, life-and-health, environmental, or key-infrastructure reasons while the assessment is completed without undue delay. This is an authority decision, not a provider self-exemption.