Direct answer
What obligations does the provider of an AI system have under Article 61 of the AI Act?
Your question is about Article 61: informed consent of test subjects for testing in real world conditions. That obligation applies today. Whether your system actually falls under it depends on conditions you assess yourself.
You determine this yourself
- Applies for the purpose of testing in real world conditions under Article 60, that is where you are a provider or prospective provider of a high-risk AI system listed in Annex III and you test that system in real world conditions outside an AI regulatory sandbox. Article 60(4), point (i), makes informed consent in accordance with Article 61 one of the cumulative conditions under which such testing is allowed. Consent is obtained per subject prior to their participation. Article 61 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
- If under Article 60(2) you test in partnership with one or more deployers or prospective deployers, the condition stays with you as the provider, even where that party is the one in contact with the subject. Article 60(4), point (h), requires you and that party to conclude an agreement specifying your tasks and responsibilities; that is where you record who informs, who obtains the consent and who keeps the file.
- The only exception sits not in Article 61 but in Article 60(4), point (i): in the case of law enforcement, where seeking informed consent would prevent the AI system from being tested in real world conditions, testing may proceed without that consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test is performed. Outside that context there is no exception to consent; Article 61 contains none of its own.
First step: Inform the test subject and obtain consent to participate.
Article 61 of the AI Act covers informed consent of test subjects for testing in real world conditions. If you test a high-risk AI system in real world conditions outside an AI regulatory sandbox, freely-given informed consent must be obtained from every test subject before they participate. Beforehand the subject receives concise, clear, relevant and understandable information on five prescribed topics: the nature and objectives of the testing and the possible inconvenience, the conditions under which the testing is to be conducted including the expected duration of participation, their rights and guarantees including the right to refuse and the right to withdraw at any time without detriment and without justification, the arrangements for requesting the reversal or the disregarding of the outputs of the system, and the Union-wide unique single identification number with the contact details from whom further information can be obtained. The consent is dated and documented and the subject is given a copy. The duty sits with the provider of an AI system. This obligation has applied since 2 August 2026.
This applies now
Your first actions
- Inform the test subject and obtain consent to participate. Give every test subject concise, clear, relevant and understandable information beforehand on the five points of Article 61(1), then obtain freely-given informed consent, date and document that consent, and give a copy to the subject or the legal representative.
General interpretation, not legal advice. Checked against Regulation (EU) 2024/1689 and the Digital Omnibus (EU) 2026/1744; the official source remains authoritative.
Full map for your situation