- 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 7
Amendments to Annex III
The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend Annex III by adding or modifying use-cases of high-risk AI systems where both of the following conditions are fulfilled:
the AI systems are intended to be used in any of the areas listed in Annex III;
the AI systems pose a risk of harm to health and safety, or an adverse impact on fundamental rights, and that risk is equivalent to, or greater than, the risk of harm or of adverse impact posed by the high-risk AI systems already referred to in Annex III.
When assessing the condition under paragraph 1, point (b), the Commission shall take into account the following criteria:
the intended purpose of the AI system;
the extent to which an AI system has been used or is likely to be used;
the nature and amount of the data processed and used by the AI system, in particular whether special categories of personal data are processed;
the extent to which the AI system acts autonomously and the possibility for a human to override a decision or recommendations that may lead to potential harm;
the extent to which the use of an AI system has already caused harm to health and safety, has had an adverse impact on fundamental rights or has given rise to significant concerns in relation to the likelihood of such harm or adverse impact, as demonstrated, for example, by reports or documented allegations submitted to national competent authorities or by other reports, as appropriate;
the potential extent of such harm or such adverse impact, in particular in terms of its intensity and its ability to affect multiple persons or to disproportionately affect a particular group of persons;
the extent to which persons who are potentially harmed or suffer an adverse impact are dependent on the outcome produced with an AI system, in particular because for practical or legal reasons it is not reasonably possible to opt-out from that outcome;
the extent to which there is an imbalance of power, or the persons who are potentially harmed or suffer an adverse impact are in a vulnerable position in relation to the deployer of an AI system, in particular due to status, authority, knowledge, economic or social circumstances, or age;
the extent to which the outcome produced involving an AI system is easily corrigible or reversible, taking into account the technical solutions available to correct or reverse it, whereby outcomes having an adverse impact on health, safety or fundamental rights, shall not be considered to be easily corrigible or reversible;
the magnitude and likelihood of benefit of the deployment of the AI system for individuals, groups, or society at large, including possible improvements in product safety;
the extent to which existing Union law provides for:
effective measures of redress in relation to the risks posed by an AI system, with the exclusion of claims for damages;
effective measures to prevent or substantially minimise those risks.
The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend the list in Annex III by removing high-risk AI systems where both of the following conditions are fulfilled:
the high-risk AI system concerned no longer poses any significant risks to fundamental rights, health or safety, taking into account the criteria listed in paragraph 2;
the deletion does not decrease the overall level of protection of health, safety and fundamental rights under Union law.
