- 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 60
Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
The Commission shall, by means of implementing acts, specify the detailed elements of the real-world testing plan. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
This paragraph shall be without prejudice to Union or national law on the testing in real world conditions of high-risk AI systems related to products covered by Union harmonisation legislation listed in Annex I.
Providers or prospective providers may conduct the testing in real world conditions only where all of the following conditions are met:
the provider or prospective provider has drawn up a real-world testing plan and submitted it to the market surveillance authority in the Member State where the testing in real world conditions is to be conducted;
the market surveillance authority in the Member State where the testing in real world conditions is to be conducted has approved the testing in real world conditions and the real-world testing plan; where the market surveillance authority has not provided an answer within 30 days, the testing in real world conditions and the real-world testing plan shall be understood to have been approved; where national law does not provide for a tacit approval, the testing in real world conditions shall remain subject to an authorisation;
the provider or prospective provider, with the exception of providers or prospective providers of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, and high-risk AI systems referred to in point 2 of Annex III has registered the testing in real world conditions in accordance with Article 71(4) with a Union-wide unique single identification number and with the information specified in Annex IX; the provider or prospective provider of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, has registered the testing in real-world conditions in the secure non-public section of the EU database according to Article 49(4), point (d), with a Union-wide unique single identification number and with the information specified therein; the provider or prospective provider of high-risk AI systems referred to in point 2 of Annex III has registered the testing in real-world conditions in accordance with Article 49(5);
the provider or prospective provider conducting the testing in real world conditions is established in the Union or has appointed a legal representative who is established in the Union;
data collected and processed for the purpose of the testing in real world conditions shall be transferred to third countries only provided that appropriate and applicable safeguards under Union law are implemented;
the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not longer than six months, which may be extended for an additional period of six months, subject to prior notification by the provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need for such an extension;
the subjects of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or disability, are appropriately protected;
where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more deployers or prospective deployers, the latter have been informed of all aspects of the testing that are relevant to their decision to participate, and given the relevant instructions for use of the AI system referred to in Article 13; the provider or prospective provider and the deployer or prospective deployer shall conclude an agreement specifying their roles and responsibilities with a view to ensuring compliance with the provisions for testing in real world conditions under this Regulation and under other applicable Union and national law;
the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the testing itself and the outcome of the testing in the real world conditions shall not have any negative effect on the subjects, and their personal data shall be deleted after the test is performed;
the testing in real world conditions is effectively overseen by the provider or prospective provider, as well as by deployers or prospective deployers through persons who are suitably qualified in the relevant field and have the necessary capacity, training and authority to perform their tasks;
the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded.
