Article 60 Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

Testing of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; in real world conditions outside AI regulatory sandboxes may be conducted by providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; listed in Annex III, in accordance with this Article and the real-world testing plan means a document that describes the objectives, methodology, geographical, population and temporal scope, monitoring, organisation and conduct of testing in real-world conditions; referred to in this Article, without prejudice to the prohibitions under Article 5.

The Commission shall, by means of implementing acts, specify the detailed elements of the real-world testing plan means a document that describes the objectives, methodology, geographical, population and temporal scope, monitoring, organisation and conduct of testing in real-world conditions;. 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 means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; related to products covered by Union harmonisation legislation listed in Annex I.

Providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; may conduct testing of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; referred to in Annex III in real world conditions at any time before the placing on the market means the first making available of an AI system or a general-purpose AI model on the Union market; or the putting into service means the supply of an AI system for first use directly to the deployer or for own use in the Union for its intended purpose; of the AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; on their own or in partnership with one or more deployers means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity; or prospective deployers means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;.

The testing of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; in real world conditions under this Article shall be without prejudice to any ethical review that is required by Union or national law.

1. the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; has drawn up a real-world testing plan means a document that describes the objectives, methodology, geographical, population and temporal scope, monitoring, organisation and conduct of testing in real-world conditions; and submitted it to the market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; in the Member State where the testing in real world conditions is to be conducted;

2. the market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; 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 means a document that describes the objectives, methodology, geographical, population and temporal scope, monitoring, organisation and conduct of testing in real-world conditions;; where the market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; has not provided an answer within 30 days, the testing in real world conditions and the real-world testing plan means a document that describes the objectives, methodology, geographical, population and temporal scope, monitoring, organisation and conduct of testing in real-world conditions; 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, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to an authorisation;

3. the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge;, with the exception of providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security;, migration, asylum and border control management, and high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; 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 means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security;, migration, asylum and border control management, has registered the testing in real-world conditions means the temporary testing of an AI system for its intended purpose in real-world conditions outside a laboratory or otherwise simulated environment, with a view to gathering reliable and robust data and to assessing and verifying the conformity of the AI system with the requirements of this Regulation and it does not qualify as placing the AI system on the market or putting it into service within the meaning of this Regulation, provided that all the conditions laid down in Article 57 or 60 are fulfilled; 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 means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; of high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; referred to in point 2 of Annex III has registered the testing in real-world conditions means the temporary testing of an AI system for its intended purpose in real-world conditions outside a laboratory or otherwise simulated environment, with a view to gathering reliable and robust data and to assessing and verifying the conformity of the AI system with the requirements of this Regulation and it does not qualify as placing the AI system on the market or putting it into service within the meaning of this Regulation, provided that all the conditions laid down in Article 57 or 60 are fulfilled; in accordance with Article 49(5);

4. the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; conducting the testing in real world conditions is established in the Union or has appointed a legal representative who is established in the Union;

5. 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;

6. 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, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; to prior notification by the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; to the market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020;, accompanied by an explanation of the need for such an extension;

7. the subjects, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or disability, are appropriately protected;

8. where a provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; organises the testing in real world conditions in cooperation with one or more deployers means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity; or prospective deployers means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity;, 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 means the information provided by the provider to inform the deployer of, in particular, an AI system’s intended purpose and proper use; of the AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; referred to in Article 13; the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; and the deployer means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity; or prospective deployer means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity; 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;

9. the subjects, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; of the testing in real world conditions have given informed consent means a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of the testing that are relevant to the subject’s decision to participate; in accordance with Article 61, or in the case of law enforcement means activities carried out by law enforcement authorities or on their behalf for the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including safeguarding against and preventing threats to public security;, where the seeking of informed consent means a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of the testing that are relevant to the subject’s decision to participate; would prevent the AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; 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, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions;, and their personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679; shall be deleted after the test is performed;

10. the testing in real world conditions is effectively overseen by the provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge;, as well as by deployers means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity; or prospective deployers means a natural or legal person, public authority, agency or other body using an AI system under its authority except where the AI system is used in the course of a personal non-professional activity; through persons who are suitably qualified in the relevant field and have the necessary capacity, training and authority to perform their tasks;

11. the predictions, recommendations or decisions of the AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; can be effectively reversed and disregarded.

Any subjects, for the purpose of real-world testing, means a natural person who participates in testing in real-world conditions; of the testing in real world conditions, or their legally designated representative, as appropriate, may, without any resulting detriment and without having to provide any justification, withdraw from the testing at any time by revoking their informed consent means a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of the testing that are relevant to the subject’s decision to participate; and may request the immediate and permanent deletion of their personal data means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679;. The withdrawal of the informed consent means a subject’s freely given, specific, unambiguous and voluntary expression of his or her willingness to participate in a particular testing in real-world conditions, after having been informed of all aspects of the testing that are relevant to the subject’s decision to participate; shall not affect the activities already carried out.

In accordance with Article 75, Member States shall confer on their market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; the powers of requiring providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; and prospective providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; to provide information, of carrying out unannounced remote or on-site inspections, and of performing checks on the conduct of the testing in real world conditions and the related high-risk AI systems means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments;. Market surveillance authorities means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; shall use those powers to ensure the safe development of testing in real world conditions.

Any serious incident means an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: the death of a person, or serious harm to a person’s health; a serious and irreversible disruption of the management or operation of critical infrastructure; the infringement of obligations under Union law intended to protect fundamental rights; serious harm to property or the environment; identified in the course of the testing in real world conditions shall be reported to the national market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; in accordance with Article 73. The provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; shall adopt immediate mitigation measures or, failing that, shall suspend the testing in real world conditions until such mitigation takes place, or otherwise terminate it. The provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; shall establish a procedure for the prompt recall of the AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments; upon such termination of the testing in real world conditions.

Providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective providers means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; shall notify the national market surveillance authority means the national authority carrying out the activities and taking the measures pursuant to Regulation (EU) 2019/1020; in the Member State where the testing in real world conditions is to be conducted of the suspension or termination of the testing in real world conditions and of the final outcomes.

The provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; or prospective provider means a natural or legal person, public authority, agency or other body that develops an AI system or a general-purpose AI model or that has an AI system or a general-purpose AI model developed and places it on the market or puts the AI system into service under its own name or trademark, whether for payment or free of charge; shall be liable under applicable Union and national liability law for any damage caused in the course of their testing in real world conditions.