- Art. 6Classification rules for high-risk AI systems
- Art. 7Amendments to Annex III
- Art. 8Compliance with the requirements
- Art. 9Risk management system
- Art. 10Data and data governance
- Art. 11Technical documentation
- Art. 12Record-keeping
- Art. 13Transparency and provision of information to deployers
- Art. 14Human oversight
- Art. 15Accuracy, robustness and cybersecurity
- Art. 16Obligations of providers of high-risk AI systems
- Art. 17Quality management system
- Art. 18Documentation keeping
- Art. 19Automatically generated logs
- Art. 20Corrective actions and duty of information
- Art. 21Cooperation with competent authorities
- Art. 22Authorised representatives of providers of high-risk AI systems
- Art. 23Obligations of importers
- Art. 24Obligations of distributors
- Art. 25Responsibilities along the AI value chain
- Art. 26Obligations of deployers of high-risk AI systems
- Art. 27Fundamental rights impact assessment for high-risk AI systems
- Art. 28Notifying authorities
- Art. 29Application of a conformity assessment body for notification
- Art. 30Notification procedure
- Art. 31Requirements relating to notified bodies
- Art. 32Presumption of conformity with requirements relating to notified bodies
- Art. 33Subsidiaries of notified bodies and subcontracting
- Art. 34Operational obligations of notified bodies
- Art. 35Identification numbers and lists of notified bodies
- Art. 36Changes to notifications
- Art. 37Challenge to the competence of notified bodies
- Art. 38Coordination of notified bodies
- Art. 39Conformity assessment bodies of third countries
- Art. 40Harmonised standards and standardisation deliverables
- Art. 41Common specifications
- Art. 42Presumption of conformity with certain requirements
- Art. 43Conformity assessment
- Art. 44Certificates
- Art. 45Information obligations of notified bodies
- Art. 46Derogation from conformity assessment procedure
- Art. 47EU declaration of conformity
- Art. 48CE marking
- Art. 49Registration
- Art. 51Classification of general-purpose AI models as general-purpose AI models with systemic risk
- Art. 52Procedure
- Art. 53Obligations for providers of general-purpose AI models
- Art. 54Authorised representatives of providers of general-purpose AI models
- Art. 55Obligations of providers of general-purpose AI models with systemic risk
- Art. 56Codes of practice
- Art. 57AI regulatory sandboxes
- Art. 58Detailed arrangements for, and functioning of, AI regulatory sandboxes
- Art. 59Further processing of personal data for developing certain AI systems in the public interest in the AI regulatory sandbox
- Art. 60Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
- Art. 60aTesting of high-risk AI systems covered by Union harmonisation legislation listed in Section B of Annex I in real-world conditions outside AI regulatory sandboxes
- Art. 61Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
- Art. 62Measures for providers and deployers, in particular SMEs, including start-ups
- Art. 63Derogations for specific operators
- Art. 64AI Office
- Art. 65Establishment and structure of the European Artificial Intelligence Board
- Art. 66Tasks of the Board
- Art. 67Advisory forum
- Art. 68Scientific panel of independent experts
- Art. 69Access to the pool of experts by the Member States
- Art. 70Designation of national competent authorities and single points of contact
- Art. 72Post-market monitoring by providers and post-market monitoring plan for high-risk AI systems
- Art. 73Reporting of serious incidents
- Art. 74Market surveillance and control of AI systems in the Union market
- Art. 75Market surveillance and control of AI systems and mutual assistance
- Art. 75aSupervisory and enforcement powers of the AI Office
- Art. 75bCommitments
- Art. 75cNon-compliance, fines and periodic penalty payments
- Art. 75dSafeguards and further specification
- Art. 76Supervision of testing in real world conditions by market surveillance authorities
- Art. 77Powers of authorities protecting fundamental rights and cooperation with market surveillance authorities
- Art. 78Confidentiality
- Art. 79Procedure at national level for dealing with AI systems presenting a risk
- Art. 80Procedure for dealing with AI systems classified by the provider as non-high-risk in application of Annex III
- Art. 81Union safeguard procedure
- Art. 82Compliant AI systems which present a risk
- Art. 83Formal non-compliance
- Art. 84Union AI testing support structures
- Art. 85Right to lodge a complaint with a market surveillance authority
- Art. 86Right to explanation of individual decision-making
- Art. 87Reporting of infringements and protection of reporting persons
- Art. 88Enforcement of the obligations of providers of general-purpose AI models
- Art. 89Monitoring actions
- Art. 90Alerts of systemic risks by the scientific panel
- Art. 91Power to request documentation and information
- Art. 92Power to conduct evaluations
- Art. 93Power to request measures
- Art. 94Procedural rights of economic operators of the general-purpose AI model
- Art. 102Amendment to Regulation (EC) No 300/2008
- Art. 103Amendment to Regulation (EU) No 167/2013
- Art. 104Amendment to Regulation (EU) No 168/2013
- Art. 105Amendment to Directive 2014/90/EU
- Art. 106Amendment to Directive (EU) 2016/797
- Art. 107Amendment to Regulation (EU) 2018/858
- Art. 108Amendments to Regulation (EU) 2018/1139
- Art. 109Amendment to Regulation (EU) 2019/2144
- Art. 110Amendment to Directive (EU) 2020/1828
- Art. 111AI systems already placed on the market or put into service and general-purpose AI models already placed on the marked
- Art. 112Evaluation and review
- Art. 113Entry into force and application
AI Act Article 6
Classification rules for high-risk AI systems
1.
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.
1a.
For the purposes of this Regulation, including paragraph 1 of this Article, AI systems that are solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control shall not qualify as safety components.
1b.
Notwithstanding paragraph 1a, AI systems the failure or malfunctioning of which would endanger health and safety shall qualify as safety components.
1c.
A product that is required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, shall not be considered as fulfilling the condition in paragraph 1, point (b).
2.
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.
3.
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.
4.
A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service. Such provider shall be subject to the registration obligation set out in Article 49(2). Upon request of national competent authorities, the provider shall provide the documentation of the assessment.
5.
The Commission shall, after consulting the European Artificial Intelligence Board (the ‘Board’), and no later than 2 February 2026, provide guidelines specifying the practical implementation of this Article in line with Article 96 together with a comprehensive list of practical examples of use cases of AI systems that are high-risk and not high-risk.
6.
The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by adding new conditions to those laid down therein, or by modifying them, where there is concrete and reliable evidence of the existence of AI systems that fall under the scope of Annex III, but do not pose a significant risk of harm to the health, safety or fundamental rights of natural persons.
7.
The Commission shall adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by deleting any of the conditions laid down therein, where there is concrete and reliable evidence that this is necessary to maintain the level of protection of health, safety and fundamental rights provided for by this Regulation.
8.
Any amendment to the conditions laid down in paragraph 3, second subparagraph, adopted in accordance with paragraphs 6 and 7 of this Article shall not decrease the overall level of protection of health, safety and fundamental rights provided for by this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and take account of market and technological developments.
Related Recitals
(26) Risk-based approach(46) Mandatory security requirements for high-risk AI systems in the EU
(47) Risk minimisation in AI systems for health and safety
(48) Fundamental rights and risk assessment of AI systems
(49) Adaptation of regulations for high-risk AI systems in safety-critical products and systems
(50) High-risk classification for AI security products
(51) High-risk AI systems and product risk
(52) Classification and regulation of high-risk AI systems
(53) Supplementing human activity and pattern recognition
(54) Risk assessment and use cases for biometric systems
(55) Classification of high-risk AI systems in critical infrastructure
(56) High-risk AI systems in education
(57) High-risk AI systems in employment and human resources
(58) High-risk AI systems deployment in social benefits, creditworthiness, and emergencies
(59) High-risk AI systems in law enforcement
(60) High-risk AI systems in migration and asylum
(61) High-risk AI systems in the administration of justice
(62) High-risk AI systems in elections
