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High-risk AI systems ​

The EU AI Act (Regulation (EU) 2024/1689, as amended by Regulation (EU) 2026/1744) has rules for high-risk AI systems in Chapter III. This page gives the Article 6 classification rules, Articles 8 to 15, Article 4a and Article 17. It also gives the fundamental-rights impact assessment in Article 27. For the other obligations of the EU AI Act, see Find the applicable obligations.

Article 6 — classification rules for high-risk AI systems ​

For providers, Article 6 of the EU AI Act sets two rules for high-risk classification:

  • Article 6(1). The AI system is a product, or a safety component of a product, in the scope of the Union harmonization legislation in Annex I. That legislation also makes a third-party conformity assessment necessary. See Article 6(1).
  • Article 6(2). Annex III refers to the AI system, unless the Article 6(3) derogation applies. See Article 6(2) and Article 6(3).

Article 2 sets the scope of the EU AI Act and its exclusions. Article 2(2) limits the provisions that apply to Article 6(1) systems related to Annex I Section B products (see scope in Article 2).

Chapter III Sections 1 to 3, other than Article 6(5), follow different Annex III and Annex I schedules, subject to Article 111 transitions.

The Commission page "Guidelines for providers and deployers of AI high-risk systems", last updated on 6 July 2026, calls the classification guidelines a draft. The page also tells the reader that the guidelines are "not legally binding" (see Guidance status).

Article 6(1) — products and safety components ​

Article 6(1) of the EU AI Act makes an AI system high-risk only if the two conditions apply together:

Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:

(a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I;

(b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.

Annex I legislative scope alone does not make an AI system high-risk in Article 6(1). Condition (b) must also apply. Article 6(1c) gives a limit to condition (b) (see Safety components). The Commission draft guidelines give an interpretation of condition (b) for legislation that permits internal control only with harmonized standards (see The two conditions).

Safety components ​

Regulation (EU) 2026/1744 changed the definition of a safety component in Article 3(14) of the EU AI Act. It also added Article 6(1a) to (1c). Article 3(14) gives this definition:

‘safety component’ means a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property; for the purposes of this definition, a component fulfils a safety function where its intended purpose is to prevent or mitigate risks to health and safety of persons or property;

Article 6 adds these rules to conditions (a) and (b):

  • Article 6(1a). AI systems that are "solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control" are not safety components. This rule applies "For the purposes of this Regulation, including paragraph 1". An AI system that is used for a safety-related aspect of these functions is not in this rule.
  • Article 6(1b). Although Article 6(1a) applies, AI systems "the failure or malfunctioning of which would endanger health and safety" are safety components.
  • Article 6(1c). A product that must have a third-party conformity assessment "solely due to risks other than risks to health and safety" does not satisfy condition (b). The example in Article 6(1c) is "in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety".

Annex I Sections A and B ​

Annex I of the EU AI Act gives the Union harmonization legislation in two sections, with different legal effects:

Annex I pointLegislation
Section A"List of Union harmonisation legislation based on the New Legislative Framework"
2Directive 2009/48/EC, "on the safety of toys"
3Directive 2013/53/EU, "on recreational craft and personal watercraft"
4Directive 2014/33/EU, "relating to lifts and safety components for lifts"
5Directive 2014/34/EU, "relating to equipment and protective systems intended for use in potentially explosive atmospheres"
6Directive 2014/53/EU, "relating to the making available on the market of radio equipment"
7Directive 2014/68/EU, "relating to the making available on the market of pressure equipment"
8Regulation (EU) 2016/424, "on cableway installations"
9Regulation (EU) 2016/425, "on personal protective equipment"
10Regulation (EU) 2016/426, "on appliances burning gaseous fuels"
11Regulation (EU) 2017/745, "on medical devices"
12Regulation (EU) 2017/746, "on in vitro diagnostic medical devices"
Section B"List of other Union harmonisation legislation"
13Regulation (EC) No 300/2008, "on common rules in the field of civil aviation security"
14Regulation (EU) No 168/2013, "on the approval and market surveillance of two- or three-wheel vehicles and quadricycles"
15Regulation (EU) No 167/2013, "on the approval and market surveillance of agricultural and forestry vehicles"
16Directive 2014/90/EU, "on marine equipment"
17Directive (EU) 2016/797, "on the interoperability of the rail system within the European Union"
18Regulation (EU) 2018/858, "on the approval and market surveillance of motor vehicles and their trailers"
19Regulation (EU) 2019/2144, "on type-approval requirements for motor vehicles and their trailers"
20Regulation (EU) 2018/1139, "on common rules in the field of civil aviation", only "where it concerns unmanned aircraft and their engines, propellers, parts and equipment to control them remotely"
21Regulation (EU) 2023/1230, "on machinery"

Regulation (EU) 2026/1744 removed the Machinery Directive 2006/42/EC (point 1) from Section A. It added the Machinery Regulation (EU) 2023/1230 to Section B as point 21 (its Article 1(41)).

For a high-risk AI system in the scope of Section A legislation, the provider follows the conformity assessment procedure of that legislation. The Chapter III Section 2 requirements apply to the system and are part of that assessment. An assessment of the Article 17 quality management system is also undertaken, and specified points of Annex VII apply (Article 43(3)). For the other Section A rules, see Annex I Section A products.

For an AI system that is high-risk in Article 6(1) and related to a product in Section B legislation, Article 2(2) of the EU AI Act applies only these provisions:

  • Article 6(1).
  • Article 60a. Member States can let providers or prospective providers test these systems in real-world conditions out of AI regulatory sandboxes. The tests examine the conformity of the systems with Articles 8 to 15.
  • Articles 102 to 112. Articles 102 to 109 amend the Section B legislation in points 13 to 20. In each of them, the Chapter III Section 2 requirements must be taken into account when specified acts, technical specifications, or testing standards are adopted. Article 102 is for "security equipment concerning Artificial Intelligence systems" in Regulation (EC) No 300/2008, and Articles 103 to 109 are for AI systems that are safety components. Article 110 amends Directive (EU) 2020/1828. Article 111 gives the transitional rules. Article 112 is the "Evaluation and review" Article.
  • Articles 57, 58 and 59, but only "in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation".

The other provisions of the EU AI Act do not apply to these systems. For example, Articles 4a, 8 to 17 and 27 do not apply to them.

For machinery, Regulation (EU) 2026/1744 also amended the Machinery Regulation (EU) 2023/1230 (its Article 3). The Commission must adopt delegated acts that add health and safety requirements for these high-risk AI systems to Annex III of that Regulation. These requirements must include the related requirements of Chapter III Section 2 and Articles 17, 19, 72 and 73 of the EU AI Act. The delegated acts "shall apply by 2 August 2028".

Article 6(2) — Annex III uses ​

Article 6(2) of the EU AI Act makes the AI systems that Annex III refers to high-risk:

In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be considered to be high-risk.

Article 6(3) gives a derogation from this rule (see Article 6(3)).

Annex III — high-risk uses ​

Annex III of the EU AI Act gives eight areas. In each area, the uses and their conditions make an AI system high-risk. The area heading alone does not make a system high-risk. Points 1, 6 and 7 apply only "in so far as their use is permitted under relevant Union or national law". Point 2 is one entry with no sub-points. Annex III gives these areas and uses:

High-risk AI systems pursuant to Article 6(2) are the AI systems listed in any of the following areas:

  1. Biometrics, in so far as their use is permitted under relevant Union or national law:

(a) remote biometric identification systems.

This shall not include AI systems intended to be used for biometric verification the sole purpose of which is to confirm that a specific natural person is the person he or she claims to be;

(b) AI systems intended to be used for biometric categorisation, according to sensitive or protected attributes or characteristics based on the inference of those attributes or characteristics;

(c) AI systems intended to be used for emotion recognition.

  1. Critical infrastructure: AI systems intended to be used as safety components in the management and operation of critical digital infrastructure, road traffic, or in the supply of water, gas, heating or electricity.

  2. Education and vocational training:

(a) AI systems intended to be used to determine access or admission or to assign natural persons to educational and vocational training institutions at all levels;

(b) AI systems intended to be used to evaluate learning outcomes, including when those outcomes are used to steer the learning process of natural persons in educational and vocational training institutions at all levels;

(c) AI systems intended to be used for the purpose of assessing the appropriate level of education that an individual will receive or will be able to access, in the context of or within educational and vocational training institutions at all levels;

(d) AI systems intended to be used for monitoring and detecting prohibited behaviour of students during tests in the context of or within educational and vocational training institutions at all levels.

  1. Employment, workers’ management and access to self-employment:

(a) AI systems intended to be used for the recruitment or selection of natural persons, in particular to place targeted job advertisements, to analyse and filter job applications, and to evaluate candidates;

(b) AI systems intended to be used to make decisions affecting terms of work-related relationships, the promotion or termination of work-related contractual relationships, to allocate tasks based on individual behaviour or personal traits or characteristics or to monitor and evaluate the performance and behaviour of persons in such relationships.

  1. Access to and enjoyment of essential private services and essential public services and benefits:

(a) AI systems intended to be used by public authorities or on behalf of public authorities to evaluate the eligibility of natural persons for essential public assistance benefits and services, including healthcare services, as well as to grant, reduce, revoke, or reclaim such benefits and services;

(b) AI systems intended to be used to evaluate the creditworthiness of natural persons or establish their credit score, with the exception of AI systems used for the purpose of detecting financial fraud;

(c) AI systems intended to be used for risk assessment and pricing in relation to natural persons in the case of life and health insurance;

(d) AI systems intended to evaluate and classify emergency calls by natural persons or to be used to dispatch, or to establish priority in the dispatching of, emergency first response services, including by police, firefighters and medical aid, as well as of emergency healthcare patient triage systems.

  1. Law enforcement, in so far as their use is permitted under relevant Union or national law:

(a) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies in support of law enforcement authorities or on their behalf to assess the risk of a natural person becoming the victim of criminal offences;

(b) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities as polygraphs or similar tools;

(c) AI systems intended to be used by or on behalf of law enforcement authorities, or by Union institutions, bodies, offices or agencies, in support of law enforcement authorities to evaluate the reliability of evidence in the course of the investigation or prosecution of criminal offences;

(d) AI systems intended to be used by law enforcement authorities or on their behalf or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for assessing the risk of a natural person offending or re-offending not solely on the basis of the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680, or to assess personality traits and characteristics or past criminal behaviour of natural persons or groups;

(e) AI systems intended to be used by or on behalf of law enforcement authorities or by Union institutions, bodies, offices or agencies in support of law enforcement authorities for the profiling of natural persons as referred to in Article 3(4) of Directive (EU) 2016/680 in the course of the detection, investigation or prosecution of criminal offences.

  1. Migration, asylum and border control management, in so far as their use is permitted under relevant Union or national law:

(a) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies as polygraphs or similar tools;

(b) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assess a risk, including a security risk, a risk of irregular migration, or a health risk, posed by a natural person who intends to enter or who has entered into the territory of a Member State;

(c) AI systems intended to be used by or on behalf of competent public authorities or by Union institutions, bodies, offices or agencies to assist competent public authorities for the examination of applications for asylum, visa or residence permits and for associated complaints with regard to the eligibility of the natural persons applying for a status, including related assessments of the reliability of evidence;

(d) AI systems intended to be used by or on behalf of competent public authorities, or by Union institutions, bodies, offices or agencies, in the context of migration, asylum or border control management, for the purpose of detecting, recognising or identifying natural persons, with the exception of the verification of travel documents.

  1. Administration of justice and democratic processes:

(a) AI systems intended to be used by a judicial authority or on their behalf to assist a judicial authority in researching and interpreting facts and the law and in applying the law to a concrete set of facts, or to be used in a similar way in alternative dispute resolution;

(b) AI systems intended to be used for influencing the outcome of an election or referendum or the voting behaviour of natural persons in the exercise of their vote in elections or referenda. This does not include AI systems to the output of which natural persons are not directly exposed, such as tools used to organise, optimise or structure political campaigns from an administrative or logistical point of view.

For the Commission draft examples for each Annex III point, see High-risk examples.

Article 6(3) — conditions for systems that are not high-risk ​

Article 6(3) of the EU AI Act gives a derogation from Article 6(2) only. It has three subparagraphs:

By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be high-risk where it does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not materially influencing the outcome of decision making.

The first subparagraph shall apply where any of the following conditions is fulfilled:

(a) the AI system is intended to perform a narrow procedural task;

(b) the AI system is intended to improve the result of a previously completed human activity;

(c) the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is not meant to replace or influence the previously completed human assessment, without proper human review; or

(d) the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III.

Notwithstanding the first subparagraph, an AI system referred to in Annex III shall always be considered to be high-risk where the AI system performs profiling of natural persons.

An AI system that Annex III refers to is not high-risk only if all of these conditions apply:

  • The system does not pose a "significant risk of harm to the health, safety or fundamental rights of natural persons". This includes that the system does "not materially" influence "the outcome of decision making".
  • One or more of conditions (a) to (d) apply to the system.
  • The system does not do profiling of natural persons. Article 3(52) uses the definition of profiling in Article 4, point (4), of Regulation (EU) 2016/679.

Article 6(3) does not apply to an AI system that is high-risk in Article 6(1).

A provider who thinks that an Annex III system is not high-risk must document its assessment before the system is placed on the market or put into service. Also, the provider must give that documentation to national competent authorities "Upon request" (Article 6(4)).

Before the system is placed on the market or put into service, that provider or, where applicable, its authorized representative must register themselves and the system in the EU database (Article 49(2)). See registration in Article 49.

For the Commission draft interpretation of the Article 6(3) conditions, see Article 6(3) in the Commission draft guidance.

Articles 8–15 — provider obligations ​

Articles 8 to 15 of the EU AI Act are the requirements for high-risk AI systems (Chapter III Section 2). Providers of high-risk AI systems must make sure that their systems comply with these requirements (Article 16(a)). Articles 8 to 15 do not apply to Article 6(1) systems related to Annex I Section B products. See Annex I Sections A and B.

Article 8 — compliance with the requirements ​

Article 8(1) of the EU AI Act gives the general rule for the Section 2 requirements:

High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.

Thus, each Section 2 requirement applies to a system in relation to its intended purpose and to the "generally acknowledged state of the art".

Article 8(2) applies to a product that contains an AI system to which the EU AI Act and Annex I Section A legislation apply. The provider is responsible for full compliance of the product with all applicable Union harmonization legislation. The provider can integrate, "as appropriate", the necessary testing and reporting processes, information and documentation into the procedures of the Section A legislation. This integration is an alternative that the provider can select. For the related Section A rules, see Annex I Section A products.

Article 9 — risk-management system ​

Article 9 of the EU AI Act tells providers of high-risk AI systems to have a risk management system. Article 9(1) gives the obligation:

A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.

Article 9(2) gives the system and its steps:

The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps:

(a) the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;

(b) the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse;

(c) the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring system referred to in Article 72;

(d) the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point (a).

The risk management system is a continuous procedure for the full lifecycle of the system. It is not one document before the system is placed on the market. Point (c) uses data from the post-market monitoring system in Article 72 (see Article 72).

Article 9 also gives these rules:

  • Risks in scope (Article 9(3)). The risks are only those "which may be reasonably mitigated or eliminated through the development or design of the high-risk AI system, or the provision of adequate technical information".

  • Combined requirements (Article 9(4)). The risk management measures give "due consideration to the effects and possible interaction resulting from the combined application of the requirements" of Section 2.

  • Residual risk (Article 9(5)). The "relevant residual risk associated with each hazard" and the overall residual risk of the system must be "judged to be acceptable". To select the measures, the provider must do these steps:

    1. Remove or decrease the risks "in as far as technically feasible through adequate design and development of the high-risk AI system".
    2. Where "appropriate", apply "adequate mitigation and control measures addressing risks that cannot be eliminated".
    3. Give the information in Article 13 and, where "appropriate", training to deployers.

    For risks related to use, "due consideration" goes to the technical knowledge, experience, education and expected training of the deployer, and to "the presumable context in which the system is intended to be used".

  • Testing (Article 9(6) to (8)). The provider tests the system to identify the most "appropriate and targeted" risk management measures. The tests make sure that the system performs consistently for its intended purpose and complies with Section 2. Testing can include testing in real-world conditions in Article 60. Testing occurs, "as appropriate", at "any time throughout the development process" and, in all cases, before the system is placed on the market or put into service. Testing uses "prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose".

  • Vulnerable groups (Article 9(9)). The provider gives "consideration to whether in view of its intended purpose the high-risk AI system is likely to have an adverse impact on persons under the age of 18 and, as appropriate, other vulnerable groups".

  • Other Union law (Article 9(10)). Other Union law can give a provider requirements for internal risk management processes. The provider can then make Article 9(1) to (9) "part of, or combined with" those procedures.

Article 10 — data and data governance ​

Article 10(1) of the EU AI Act, as amended, gives the data rule for systems that use the training of AI models:

High-risk AI systems which make use of techniques involving the training of AI models with data shall be developed on the basis of training, validation and testing data sets that meet the quality criteria referred to in paragraphs 2, 3 and 4 of this Article and in Article 4a(1) whenever such data sets are used.

Article 10(2) gives the data governance and management practices for training, validation and testing data sets:

Training, validation and testing data sets shall be subject to data governance and management practices appropriate for the intended purpose of the high-risk AI system. Those practices shall concern in particular:

(a) the relevant design choices;

(b) data collection processes and the origin of data, and in the case of personal data, the original purpose of the data collection;

(c) relevant data-preparation processing operations, such as annotation, labelling, cleaning, updating, enrichment and aggregation;

(d) the formulation of assumptions, in particular with respect to the information that the data are supposed to measure and represent;

(e) an assessment of the availability, quantity and suitability of the data sets that are needed;

(f) examination in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited under Union law, especially where data outputs influence inputs for future operations;

(g) appropriate measures to detect, prevent and mitigate possible biases identified according to point (f);

(h) the identification of relevant data gaps or shortcomings that prevent compliance with this Regulation, and how those gaps and shortcomings can be addressed.

Article 10(3) tells providers that the data sets must be "relevant, sufficiently representative, and to the best extent possible, free of errors and complete in view of the intended purpose". The data sets must also have "the appropriate statistical properties", where applicable for the persons or groups on whom the system is intended for use. Each data set, or a combination of data sets, can have these characteristics.

Article 10(4) tells providers that the data sets "shall take into account, to the extent required by the intended purpose, the characteristics or elements that are particular to the specific geographical, contextual, behavioural or functional setting" of use.

Regulation (EU) 2026/1744 removed Article 10(5). Article 4a has the rules for the processing of special categories of personal data for bias detection and correction (see Article 4a).

Article 10(6) applies to high-risk AI systems that do not use the training of AI models. For these systems, Article 10(2) to (4) and Article 4a(1) apply only to the testing data sets.

Article 11 — technical documentation ​

Article 11(1) of the EU AI Act tells providers to prepare the technical documentation of a high-risk AI system before the system is placed on the market or put into service. Also, the provider must keep the documentation up to date. Thus, the documentation is a current record for the life of the system. Article 11(1) continues:

That technical documentation shall be drawn up in such a way as to demonstrate that the high-risk AI system complies with the requirements set out in this Section and to provide national competent authorities and notified bodies with the necessary information in a clear and comprehensive form to assess the compliance of the AI system with those requirements. It shall contain, at a minimum, the elements set out in Annex IV. […]

Annex IV gives the minimum content of the technical documentation, "as applicable to the relevant AI system":

  1. A general description of the AI system. Examples are its intended purpose, versions, forms of supply, hardware and instructions for use.
  2. A "detailed description of the elements of the AI system and of the process for its development". Examples are the "design specifications of the system", the system architecture, data requirements, human oversight assessment, pre-determined changes, and validation and testing procedures. Where "relevant", data requirements include datasheets about training methodologies, techniques and training data sets used (Annex IV point 2(d)).
  3. Information about the monitoring, functioning and control of the system, for example its capabilities and limitations in performance.
  4. A description of the appropriateness of the performance metrics.
  5. A "detailed description of the risk management system in accordance with Article 9".
  6. A description of "relevant changes made by the provider to the system through its lifecycle".
  7. The "list of the harmonised standards applied in full or in part" with "references" published in the Official Journal of the European Union. Where the provider applied no such standards, a detailed description of solutions adopted for compliance with Chapter III Section 2. This includes a "list of other relevant standards and technical specifications applied".
  8. A copy of the EU declaration of conformity in Article 47.
  9. A "detailed description of the system in place to evaluate the AI system performance in the post-market phase in accordance with Article 72, including the post-market monitoring plan referred to in Article 72(3)".

Article 11(2) applies to a high-risk AI system related to a product in Annex I Section A legislation. For such a system, the provider prepares "a single set of technical documentation". The set contains the information in Article 11(1) and the information that the Section A legislation makes necessary.

For the simplified technical documentation of SMEs and SMCs, see SMEs and SMCs.

Article 12 — record-keeping (logging) ​

Article 12(1) of the EU AI Act gives the logging requirement:

High-risk AI systems shall technically allow for the automatic recording of events (logs) over the lifetime of the system.

Article 12(2) gives the events that the logging capabilities must record:

In order to ensure a level of traceability of the functioning of a high-risk AI system that is appropriate to the intended purpose of the system, logging capabilities shall enable the recording of events relevant for:

(a) identifying situations that may result in the high-risk AI system presenting a risk within the meaning of Article 79(1) or in a substantial modification;

(b) facilitating the post-market monitoring referred to in Article 72; and

(c) monitoring the operation of high-risk AI systems referred to in Article 26(5).

Article 12(3) gives the minimum logging capabilities for remote biometric identification systems:

For high-risk AI systems referred to in point 1 (a), of Annex III, the logging capabilities shall provide, at a minimum:

(a) recording of the period of each use of the system (start date and time and end date and time of each use);

(b) the reference database against which input data has been checked by the system;

(c) the input data for which the search has led to a match;

(d) the identification of the natural persons involved in the verification of the results, as referred to in Article 14(5).

Article 19 tells providers to keep the logs that their high-risk AI systems make automatically, when and while those logs are in their control, for the period that Article 19 gives. See provider obligations in Article 16.

Article 13 — transparency and provision of information to deployers ​

Article 13(1) of the EU AI Act gives the transparency requirement for high-risk AI systems:

High-risk AI systems shall be designed and developed in such a way as to ensure that their operation is sufficiently transparent to enable deployers to interpret a system’s output and use it appropriately. An appropriate type and degree of transparency shall be ensured with a view to achieving compliance with the relevant obligations of the provider and deployer set out in Section 3.

Article 13(2) tells providers to supply instructions for use with each high-risk AI system, "in an appropriate digital format or otherwise". The information must be "concise, complete, correct and clear" and "relevant, accessible and comprehensible to deployers". Article 13(3) gives the minimum content:

The instructions for use shall contain at least the following information:

(a) the identity and the contact details of the provider and, where applicable, of its authorised representative;

(b) the characteristics, capabilities and limitations of performance of the high-risk AI system, including:

(i) its intended purpose;

(ii) the level of accuracy, including its metrics, robustness and cybersecurity referred to in Article 15 against which the high-risk AI system has been tested and validated and which can be expected, and any known and foreseeable circumstances that may have an impact on that expected level of accuracy, robustness and cybersecurity;

(iii) any known or foreseeable circumstance, related to the use of the high-risk AI system in accordance with its intended purpose or under conditions of reasonably foreseeable misuse, which may lead to risks to the health and safety or fundamental rights referred to in Article 9(2);

(iv) where applicable, the technical capabilities and characteristics of the high-risk AI system to provide information that is relevant to explain its output;

(v) when appropriate, its performance regarding specific persons or groups of persons on which the system is intended to be used;

(vi) when appropriate, specifications for the input data, or any other relevant information in terms of the training, validation and testing data sets used, taking into account the intended purpose of the high-risk AI system;

(vii) where applicable, information to enable deployers to interpret the output of the high-risk AI system and use it appropriately;

(c) the changes to the high-risk AI system and its performance which have been pre-determined by the provider at the moment of the initial conformity assessment, if any;

(d) the human oversight measures referred to in Article 14, including the technical measures put in place to facilitate the interpretation of the outputs of the high-risk AI systems by the deployers;

(e) the computational and hardware resources needed, the expected lifetime of the high-risk AI system and any necessary maintenance and care measures, including their frequency, to ensure the proper functioning of that AI system, including as regards software updates;

(f) where relevant, a description of the mechanisms included within the high-risk AI system that allows deployers to properly collect, store and interpret the logs in accordance with Article 12.

Article 14 — human oversight ​

Article 14(1) of the EU AI Act gives the human oversight requirement:

High-risk AI systems shall be designed and developed in such a way, including with appropriate human-machine interface tools, that they can be effectively overseen by natural persons during the period in which they are in use.

Human oversight "shall aim to prevent or minimise the risks to health, safety or fundamental rights" in use for the intended purpose or with reasonably foreseeable misuse. This applies "in particular where such risks persist despite the application of other requirements" of Section 2 (Article 14(2)).

Article 14(3) tells providers that the oversight measures must be "commensurate with the risks, level of autonomy and context of use". The measures must use one or more of these types:

  • Measures that the provider identifies and puts into the system, "when technically feasible", before the system is placed on the market or put into service (point (a)).
  • Measures that the provider identifies before the system is placed on the market or put into service, and that are "appropriate to be implemented by the deployer" (point (b)).

Article 14(4) tells providers how to supply the system to the deployer:

For the purpose of implementing paragraphs 1, 2 and 3, the high-risk AI system shall be provided to the deployer in such a way that natural persons to whom human oversight is assigned are enabled, as appropriate and proportionate:

(a) to properly understand the relevant capacities and limitations of the high-risk AI system and be able to duly monitor its operation, including in view of detecting and addressing anomalies, dysfunctions and unexpected performance;

(b) to remain aware of the possible tendency of automatically relying or over-relying on the output produced by a high-risk AI system (automation bias), in particular for high-risk AI systems used to provide information or recommendations for decisions to be taken by natural persons;

(c) to correctly interpret the high-risk AI system’s output, taking into account, for example, the interpretation tools and methods available;

(d) to decide, in any particular situation, not to use the high-risk AI system or to otherwise disregard, override or reverse the output of the high-risk AI system;

(e) to intervene in the operation of the high-risk AI system or interrupt the system through a ‘stop’ button or a similar procedure that allows the system to come to a halt in a safe state.

Article 14(5) applies to remote biometric identification systems in Annex III, point 1(a). The Article 14(3) measures must also make sure that the deployer acts or decides on an identification from the system only if two or more natural persons independently verified and confirmed it. These persons must have "the necessary competence, training and authority". This rule does not apply to high-risk AI systems for law enforcement, migration, border control or asylum, where Union or national law considers it "disproportionate".

Deployers must give the human oversight task to natural persons who have "the necessary competence, training and authority, as well as the necessary support" (Article 26(2)). See deployer obligations in Article 26.

Article 15 — accuracy, robustness and cybersecurity ​

Article 15(1) of the EU AI Act gives the requirement for accuracy, robustness and cybersecurity:

High-risk AI systems shall be designed and developed in such a way that they achieve an appropriate level of accuracy, robustness, and cybersecurity, and that they perform consistently in those respects throughout their lifecycle.

Article 15 also gives these rules:

  • Benchmarks (Article 15(2)). The Commission must encourage, "as appropriate", the development of benchmarks and measurement methods. It does this in cooperation with stakeholders and organizations, for example metrology and benchmarking authorities.
  • Declared accuracy (Article 15(3)). The instructions for use must declare the levels of accuracy and the related accuracy metrics of the system.
  • Robustness (Article 15(4)). High-risk AI systems must be "as resilient as possible regarding errors, faults or inconsistencies" in the system or its environment. Technical and organizational measures are necessary for this. Robustness can use technical redundancy solutions, for example "backup or fail-safe plans".
  • Feedback loops (Article 15(4)). Some systems "continue to learn after being placed on the market or put into service". These systems must be developed to remove or decrease "as far as possible" the risk of "possibly biased outputs influencing input for future operations (feedback loops)". Such feedback loops must have "appropriate mitigation measures".
  • Cybersecurity (Article 15(5)). High-risk AI systems must be resilient against "attempts by unauthorised third parties to alter their use, outputs or performance by exploiting system vulnerabilities". The technical solutions must be "appropriate to the relevant circumstances and the risks".
  • AI-specific vulnerabilities (Article 15(5)). The solutions include, where "appropriate", "measures to prevent, detect, respond to, resolve and control for attacks". Examples are data poisoning, model poisoning, adversarial examples or model evasion, confidentiality attacks and model flaws.

Article 4a — bias detection and correction ​

Article 4a of the EU AI Act permits providers and deployers to process special categories of personal data exceptionally for bias detection and correction on its conditions. Regulation (EU) 2026/1744 entered into force on 27 July 2026. It added Article 4a in Chapter I and removed Article 10(5). For the special categories, Article 3(37) refers to Regulation (EU) 2016/679, Directive (EU) 2016/680 and Regulation (EU) 2018/1725.

Article 4a(1) applies to providers of high-risk AI systems:

To the extent strictly necessary to ensure bias detection and correction in relation to high-risk AI systems in accordance with Article 10(2), points (f) and (g), of this Regulation, providers of such systems may exceptionally process special categories of personal data, subject to appropriate safeguards for the fundamental rights and freedoms of natural persons. In addition to the provisions set out in Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable, all the following conditions shall be met in order for such processing to occur:

(a) the bias detection and correction cannot be effectively fulfilled by processing other data, including synthetic or anonymised data;

(b) the special categories of personal data are subject to technical limitations on the re-use of personal data, and state-of-the-art security and privacy-preserving measures, including pseudonymisation;

(c) the special categories of personal data are subject to measures to ensure that the personal data processed are secured and protected, subject to suitable safeguards, including strict controls and documentation of the access, to avoid misuse and to ensure that only authorised persons have access to those personal data with appropriate confidentiality obligations;

(d) the special categories of personal data are not transmitted, transferred or otherwise accessed by other parties;

(e) the special categories of personal data are deleted once the bias has been corrected or the personal data has reached the end of its retention period, whichever comes first; and

(f) the records of processing activities pursuant to Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680 include the reasons why the processing of special categories of personal data was strictly necessary to detect and correct biases, and why that objective could not be achieved by processing other data.

Article 4a(2) applies to providers and deployers of other AI systems and models, and to deployers of high-risk AI systems. They can "exceptionally process special categories of personal data" only if the two conditions in Article 4a(2) apply together:

  • The processing is "strictly necessary to ensure bias detection and correction in view of possible biases that are likely to affect the health and safety of persons, have a negative impact on fundamental rights or lead to discrimination prohibited pursuant to Union law, especially where data outputs influence inputs for future operations".
  • "all of the conditions and safeguards set out in paragraph 1 are applied".

Article 4a(2) "does not create any obligation to conduct such bias detection and correction".

Article 2(7) preserves Union data-protection law for personal data processed in connection with EU AI Act rights and obligations, without prejudice to Articles 4a and 59. Article 4a does not apply to Article 6(1) systems related to Annex I Section B products (Article 2(2)).

Article 17 — quality-management system (QMS) ​

Article 17(1) of the EU AI Act gives the quality management system of providers of high-risk AI systems:

Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation. That system shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions, and shall include at least the following aspects:

(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for the management of modifications to the high-risk AI system;

(b) techniques, procedures and systematic actions to be used for the design, design control and design verification of the high-risk AI system;

(c) techniques, procedures and systematic actions to be used for the development, quality control and quality assurance of the high-risk AI system;

(d) examination, test and validation procedures to be carried out before, during and after the development of the high-risk AI system, and the frequency with which they have to be carried out;

(e) technical specifications, including standards, to be applied and, where the relevant harmonised standards are not applied in full or do not cover all of the relevant requirements set out in Section 2, the means to be used to ensure that the high-risk AI system complies with those requirements;

(f) systems and procedures for data management, including data acquisition, data collection, data analysis, data labelling, data storage, data filtration, data mining, data aggregation, data retention and any other operation regarding the data that is performed before and for the purpose of the placing on the market or the putting into service of high-risk AI systems;

(g) the risk management system referred to in Article 9;

(h) the setting-up, implementation and maintenance of a post-market monitoring system, in accordance with Article 72;

(i) procedures related to the reporting of a serious incident in accordance with Article 73;

(j) the handling of communication with national competent authorities, other relevant authorities, including those providing or supporting the access to data, notified bodies, other operators, customers or other interested parties;

(k) systems and procedures for record-keeping of all relevant documentation and information;

(l) resource management, including security-of-supply related measures;

(m) an accountability framework setting out the responsibilities of the management and other staff with regard to all the aspects listed in this paragraph.

Article 17 also gives these rules:

  • Proportionality (Article 17(2)). The implementation of the Article 17(1) aspects is "proportionate to the size of the provider’s organisation, in particular, if the provider is an SME, including a start-up, or an SMC". Providers must, in all cases, keep "the degree of rigour and the level of protection required" for compliance of their high-risk AI systems.
  • Sectoral systems (Article 17(3)). A provider with obligations for a quality management system, or an equivalent function, in sectoral Union law can include the Article 17(1) aspects in that system.
  • Financial institutions (Article 17(4)). Some providers are financial institutions with requirements for internal governance in Union financial services law. For these providers, the quality management system obligation "shall be deemed to be fulfilled" through compliance with those rules. This does not apply to points (g), (h) and (i) of Article 17(1). The harmonized standards in Article 40 "shall be taken into account" for this.

Conformity with harmonized standards that have their references in the Official Journal gives a presumption of conformity only "to the extent that those standards cover those requirements or obligations" (Article 40(1)). See Standards and common specifications.

Implementing Decision (EU) 2026/2274 published EN 18286:2026's "reference" on 14 October 2026, with presumption only for Article 17(1) and the first sentence of Article 11(1), on each Annex ZA Table ZA.1 row's conditions.

SMEs and SMCs ​

Article 3(14a) of the EU AI Act uses the definition of micro, small and medium-sized enterprises (SMEs) in Recommendation 2003/361/EC. Article 3(14b) uses the definition of small mid-cap enterprises (SMCs) in Recommendation (EU) 2025/1099. The EU AI Act has these rules for SMEs and SMCs:

  • Technical documentation (Article 11(1)). SMEs, "including start-ups", and SMCs can supply the Annex IV elements "in a simplified manner". If they do this, they must use the "simplified technical documentation form" of the Commission. Notified bodies must accept it for the conformity assessment.
  • Quality management system (Article 17(2)). The implementation of the quality management system is proportionate, as Article 17 gives.
  • Simplified quality management system (Article 63(1)). SMEs, "including start-ups", can comply with "certain elements" of the Article 17 quality management system "in a simplified manner". This applies only if they do not have partner enterprises or linked enterprises in the meaning of Recommendation 2003/361/EC. The Commission must prepare guidelines on these elements.
  • Other obligations (Article 63(2)). Article 63(1) does not release these operators from the other requirements and obligations of the EU AI Act. These include Articles 9 to 15, 72 and 73.

Annex I Section A products ​

The EU AI Act has these rules for high-risk AI systems related to products in Annex I Section A legislation:

  • Conditional limits (Article 2(13)). For Article 6(1) high-risk AI systems, the application of specified requirements or obligations in Articles 9 to 15 and 17 to 25 can have limits. All of these conditions must apply:

    • Section A legislation gives "an equivalent or higher level of protection of health, safety or fundamental rights" than the requirement or obligation.
    • The limit "does not reduce the overall level of protection" of the EU AI Act.

    By 2 August 2027, the Commission must adopt delegated acts that specify the systems, the requirements or obligations, the conditions and the scope of the limits.

  • Integration (Article 8(2)). The provider can integrate testing, reporting, information and documentation into the Section A procedures. See Article 8.

  • Risk management (Article 9(10)). Where other Union law gives requirements for internal risk management processes, Article 9 can be "part of, or combined with" those procedures. See Article 9.

  • Technical documentation (Article 11(2)). The provider prepares a single set of technical documentation. See Article 11.

  • Quality management system (Article 17(3)). The provider can include the Article 17(1) aspects in a sectoral quality management system.

  • Guidelines (Article 96(1)(g)). The Commission must publish guidelines on the practical implementation of Article 8(2), Article 9(10) and Article 17(3) by 1 August 2027.

Article 27 — fundamental-rights impact assessment (FRIA) ​

Article 27(1) of the EU AI Act tells specified deployers to do a fundamental-rights impact assessment before they deploy a high-risk AI system:

Prior to deploying a high-risk AI system referred to in Article 6(2), with the exception of high-risk AI systems intended to be used in the area listed in point 2 of Annex III, deployers that are bodies governed by public law, or are private entities providing public services, and deployers of high-risk AI systems referred to in points 5 (b) and (c) of Annex III, shall perform an assessment of the impact on fundamental rights that the use of such system may produce. For that purpose, deployers shall perform an assessment consisting of:

(a) a description of the deployer’s processes in which the high-risk AI system will be used in line with its intended purpose;

(b) a description of the period of time within which, and the frequency with which, each high-risk AI system is intended to be used;

(c) the categories of natural persons and groups likely to be affected by its use in the specific context;

(d) the specific risks of harm likely to have an impact on the categories of natural persons or groups of persons identified pursuant to point (c) of this paragraph, taking into account the information given by the provider pursuant to Article 13;

(e) a description of the implementation of human oversight measures, according to the instructions for use;

(f) the measures to be taken in the case of the materialisation of those risks, including the arrangements for internal governance and complaint mechanisms.

Thus, the obligation applies only to these deployers:

  • Deployers that are bodies governed by public law.
  • Deployers that are private entities that give public services.
  • Deployers of these high-risk AI systems in Annex III:
    • Point 5(b): creditworthiness and credit score systems, with the exception of systems for the detection of financial fraud.
    • Point 5(c): systems for risk assessment and pricing in life and health insurance.

The obligation applies only to high-risk AI systems in Article 6(2). It does not apply to systems intended for use in the area of Annex III, point 2 (critical infrastructure).

Article 27 also gives these rules:

  • First use (Article 27(2)). The obligation applies to the first use of the system. The deployer can, "in similar cases", use previous fundamental-rights impact assessments or the impact assessments of the provider. If, during use, the deployer thinks that one or more Article 27(1) items changed or are not up to date, the deployer must update the information.
  • Notification (Article 27(3)). After the assessment, the deployer must notify the market surveillance authority of its results. The notification includes the completed template of Article 27(5). Where Article 46(1) applies, deployers "may be exempt" from this notification.
  • Data protection impact assessment (Article 27(4)). Article 27(4) applies "If any of the obligations laid down in this Article is already met through the data protection impact assessment" in Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680. The deployer can then refer to the related sections of that assessment, or include related parts of it in the fundamental-rights impact assessment. The other Article 27 obligations stay.
  • Template (Article 27(5)). The AI Office must prepare a template for a questionnaire, also through an automated tool, to help deployers comply in a simplified manner. The template, "where relevant", lets deployers refer to or include parts of the data protection impact assessment.

Article 27 follows the Annex III schedule and Article 111 transitions for Chapter III Section 3.

Article 5(2) makes a completed FRIA and EU-database registration prerequisites for authorized real-time remote biometric identification in publicly accessible spaces for law enforcement, subject to the registration exception for "duly justified cases of urgency".

Where applicable, deployers must use the Article 13 information for their data protection impact assessment in Regulation (EU) 2016/679 or Directive (EU) 2016/680 (Article 26(9)). See deployer obligations in Article 26.

Conformity assessment ​

Providers must make sure that each high-risk AI system undergoes the applicable conformity assessment before it is placed on the market or put into service (EU AI Act, Article 16(f)). The Section B exclusion and the Article 46 derogation rules qualify this duty. Article 43 sets the Annex VI, Annex VII and sectoral routes. Article 43(3), last subparagraph, covers a high-risk AI system that is covered by the Union harmonization legislation in Annex I Section A and is also in an Annex III category. The provider of that system follows the conformity assessment procedure that the applicable Section A legislation requires.

Modulos ​

Modulos has two EU AI Act Frameworks: OFF-1 at Organization level and MFF-1 at AI System level (see Select the Frameworks). For the Requirements that map Articles 4a, 6, 8 to 15, 17 and 27, see Requirements and provisions.

For the sequence that Modulos recommends to providers, see Complete the work in sequence.

Sources ​

Disclaimer

This page gives general information. It is not legal advice.