Article 60a: Testing 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
1.
Member States may allow, in accordance with this Article, the testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes by providers or prospective providers of AI enabled products covered by the Union harmonisation legislation listed in Section B of Annex I, with a view to assessing and verifying the conformity of those systems with the requirements laid down in Articles 8 to 15.Not present before the amendment.
2.
Member States that choose to allow testing as referred to in paragraph 1 shall, individually or jointly, adopt frameworks for real-world testing.Not present before the amendment.
3.
Each Member State shall notify the Commission of any real-world testing framework it adopts before implementing it. This shall not affect the competences of the Commission under the Union harmonisation legislation listed in Section B of Annex I.Not present before the amendment.
4.
Member States that have adopted real-world testing frameworks shall ensure that the relevant national competent authorities, relevant authorities and public authorities responsible for the management and operation of infrastructure and products covered by Union harmonisation legislation listed in Section B of Annex I cooperate closely with each other in good faith and remove any practical obstacles, including on procedural rules providing access to physical public infrastructure, where this is necessary, to successfully implement those real-world testing frameworks and test AI-enabled products covered by Union harmonisation legislation listed in Section B of Annex I.Not present before the amendment.
5.
The frameworks for real-world testing shall lay down the requirements under which testing in real-world conditionstesting in real-world conditionsmeans the temporary testing of an AI systemAI systemmeans 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 environmentsArticle 3(1) for its intended purposeintended purposemeans the use for which an AI systemAI systemmeans 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 environmentsArticle 3(1) is intended by the providerprovidermeans 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 chargeArticle 3(3), including the specific context and conditions of use, as specified in the information supplied by the providerprovidermeans 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 chargeArticle 3(3) in the instructions for use, promotional or sales materials and statements, as well as in the technical documentationArticle 3(12) 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 systemAI systemmeans 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 environmentsArticle 3(1) with the requirements of this Regulation and it does not qualify as placing the AI systemAI systemmeans 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 environmentsArticle 3(1) 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 fulfilledArticle 3(57) shall occur. Those frameworks shall:Not present before the amendment.
(a)
include the provision of a mandatory real-world testing planreal-world testing planmeans a document that describes the objectives, methodology, geographical, population and temporal scope, monitoring, organisation and conduct of testing in real-world conditionsArticle 3(53) to be agreed between the providerprovidermeans 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 chargeArticle 3(3) or prospective providerprovidermeans 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 chargeArticle 3(3) and the national competent authoritynational competent authoritymeans a notifying authoritynotifying authoritymeans the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoringArticle 3(19) or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection SupervisorArticle 3(48) or relevant authority in accordance with the Union harmonisation legislation listed in Section B of Annex I;Not present before the amendment.
(b)
ensure compliance with the requirements laid down in Article 60(2), (3), (4)(d)-(j) and (5)-(9), where any reference to market surveillance authorities in those provisions shall be read as a reference to the national competent authoritynational competent authoritymeans a notifying authoritynotifying authoritymeans the national authority responsible for setting up and carrying out the necessary procedures for the assessment, designation and notification of conformity assessment bodies and for their monitoringArticle 3(19) or a market surveillance authority; as regards AI systems put into service or used by Union institutions, agencies, offices and bodies, references to national competent authorities or market surveillance authorities in this Regulation shall be construed as references to the European Data Protection SupervisorArticle 3(48) or relevant authority, as appropriate in accordance with the Union harmonisation legislation listed in Section B of Annex I;Not present before the amendment.
(c)
include effective governance and accountability arrangements;Not present before the amendment.
(d)
ensure a high level of protection of health safety and fundamental rightsfundamental rightsIncludes human dignity, right to life, prohibition of torture, protection of personal datapersonal dataAny information relating to an identified or identifiable natural person ('data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)data subjectsubjectfor the purpose of real-world testing, means a natural person who participates in testing in real-world conditionsArticle 3(58)An identified or identifiable natural person to whom personal data relateGDPR Art. 4(1)'). Includes name, ID number, location data, online identifiers, or factors specific to physical, physiological, genetic, mental, economic, cultural or social identityGDPR Art. 4(1), freedom of expression, non-discrimination, equality between women and men, rights of the child, right to an effective remedy and fair trialCharter of Fundamental Rights Art. 1–54.Not present before the amendment.
6.
The real-world testing shall comply with the applicable provisions laid down in the Union harmonisation legislation listed in Section B of Annex I. Any requirements laid down in those provisions shall not affect the application of this Article to the extent necessary to enable the testing referred to in paragraph 1.Not present before the amendment.