AI Act, Articles 60 and 61 (testing in real world conditions outside AI regulatory sandboxes, with informed consent)

Providers or prospective providers of high-risk AI systems listed in Annex III or covered by the Union harmonisation legislation listed in Section A of Annex I may test them in real world conditions outside AI regulatory sandboxes, in accordance with Article 60 and the real-world testing plan, without prejudice to the prohibitions under Article 5.

They may conduct that testing at any time before the placing on the market or the putting into service of the system, on their own or in partnership with one or more deployers or prospective deployers. A provider is a natural or legal person, public authority, agency or other body that develops an AI system, or has one developed, and places it on the market or puts it into service under its own name or trademark, whether for payment or free of charge.

Article 2(8) excludes research, testing and development activity regarding AI systems prior to their being placed on the market or put into service, but testing in real world conditions is not covered by that exclusion. The testing is without prejudice to any ethical review that is required by Union or national law.

Providers or prospective providers may conduct the testing in real world conditions only where all of the conditions in Article 60(4) are met, the first being that they have drawn up a real-world testing plan and submitted it to the market surveillance authority in the Member State where the testing is to be conducted.

The market surveillance authority in that Member State must have approved the testing and the plan, and where it has not answered within 30 days they are understood to have been approved, although where national law does not provide for a tacit approval the testing remains subject to an authorisation.

The provider or prospective provider must have registered the testing in accordance with Article 71(4) with a Union-wide unique single identification number and the information specified in Annex IX, subject to separate registration routes for Annex III point 1, 6 and 7 systems in the areas of law enforcement, migration, asylum and border control management and for point 2 systems.

The provider or prospective provider must be established in the Union or have appointed a legal representative established in the Union, may transfer data collected for the testing to third countries only with appropriate and applicable safeguards under Union law, and may not test for longer than necessary and in any case not longer than six months, extendable by six months on prior notification with an explanation.

Subjects who belong to vulnerable groups due to their age or disability must be appropriately protected, and where deployers or prospective deployers take part they must be informed of all aspects of the testing relevant to their decision to participate, given the instructions for use referred to in Article 13, and bound by an agreement specifying roles and responsibilities. The subjects of the testing must have given informed consent in accordance with Article 61.

In the case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the testing itself and its outcome must not have any negative effect on the subjects and their personal data must be deleted after the test is performed.

The testing must be effectively overseen by the provider or prospective provider, and by deployers or prospective deployers, through suitably qualified persons with the necessary capacity, training and authority, and the predictions, recommendations or decisions of the AI system must be capable of being effectively reversed and disregarded.

Under Article 61(1), freely-given informed consent must be obtained from the subjects of testing prior to their participation, after they have been duly informed of the nature and objectives of the testing, its conditions and expected duration, their rights, the arrangements for requesting the reversal or the disregarding of the system's predictions, recommendations or decisions, and the Union-wide unique single identification number of the testing and the contact details of the provider or its legal representative.

The informed consent must be dated and documented and a copy given to the subjects of testing or their legal representative. Subjects, or their legally designated representative, may without any resulting detriment and without having to provide any justification withdraw from the testing at any time by revoking their informed consent and may request the immediate and permanent deletion of their personal data, and the withdrawal does not affect the activities already carried out.

A serious incident is an incident or malfunctioning of an AI system that directly or indirectly leads to 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, or serious harm to property or the environment.

Article 60(7) requires any serious incident identified in the course of the testing in real world conditions to be reported to the national market surveillance authority in accordance with Article 73. The provider or prospective provider must adopt immediate mitigation measures or, failing that, suspend the testing until such mitigation takes place, or otherwise terminate it.

The provider or prospective provider must also establish a procedure for the prompt recall of the AI system upon such termination of the testing.

Article 73 requires the report immediately after a causal link, or the reasonable likelihood of one, is established and in any event not later than 15 days after becoming aware of the serious incident, not later than two days in the event of a widespread infringement or a serious and irreversible disruption of critical infrastructure, and not later than 10 days after becoming aware of the serious incident in the event of the death of a person.

Providers or prospective providers must notify the national market surveillance authority in the Member State where the testing is to be conducted of the suspension or termination of the testing and of the final outcomes. The provider or prospective provider is liable under applicable Union and national liability law for any damage caused in the course of their testing in real world conditions.

Member States must confer on their market surveillance authorities the powers of requiring providers and prospective providers to provide information, of carrying out unannounced remote or on-site inspections, and of performing checks on the conduct of the testing and the related high-risk AI systems.

Member States lay down the rules on penalties and other enforcement measures, which may also include administrative fines, warnings and non-monetary measures, applicable to any infringement of the Regulation by operators. Article 113 provides that the Regulation applies from 2 August 2026, with exceptions for Chapters I and II, Chapter III Section 4, Chapter V, Chapter VII, Chapter XII, Article 78 and Article 6(1), none of which is Chapter VI, which holds Articles 60 and 61.

Regulation (EU) 2026/1744 replaced point (c) of Article 113, third paragraph, which now dates Chapter III, Sections 1, 2 and 3, and added a point (d) dating Articles 102 to 110 from 27 July 2026. Regulation (EU) 2026/1744 entered into force on the third day following that of its publication in the Official Journal, 27 July 2026.