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Regulation Tracker / EU AI Act / Chapter VI

Article 61
Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes

Chapter VI — AI regulatory sandboxes. 2 distinct duties, powers or definitions are coded from this article, applying from 2026-08-02.

official text: EUR-Lex (consolidated 27 Jul 2026) · text © European Union (Decision 2011/833/EU) · coding CC BY 4.0 · data: obligations.json · Hugging Face · GitHub

The text

1. For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding:

  1. (a)the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
  2. (b)the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;
  3. (c)their rights, and the guarantees regarding their participation, in particular their right to refuse to participate in, and the right to withdraw from, testing in real world conditions at any time without any resulting detriment and without having to provide any justification;
  4. (d)the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
  5. (e)the Union-wide unique single identification number of the testing in real world conditions in accordance with Article 60(4) point (c), and the contact details of the provider or its legal representative from whom further information can be obtained.

2. The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.

What it requires, coded

SafeLegalAI's reading of each duty in this article: who, what, from when, under which fine tier, and whether it reaches a firm, chambers, court or legal-AI vendor. Descriptive, not advice; the quoted words are the Regulation's.

  1. Art. 61(1)Information to personsHigh-risk

    For Article 60 real-world testing, freely given informed consent must be obtained before participation after concise, clear, relevant and understandable information on nature, conditions, rights, reversal arrangements and identification/contact details.

    "For the purpose of testing in real world conditions under Article 60, freely-given informed consent shall be obtained from the subjects of testing prior to their participation in such testing and after their having been duly informed with concise, clear, relevant, and understandable information regarding:"
    Who
    Provider
    From
    (Art. 113 second subparagraph)
    Legal practice
    Reaches legal-AI vendors or public bodies — Medium for legal-AI vendors testing high-risk systems with natural-person subjects.
    See
    Art. 60

  2. Art. 61(2)Record keepingHigh-risk

    Informed consent for Article 60 real-world testing must be dated and documented, and a copy must be given to the test subject or legal representative.

    "The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative."
    Who
    Provider
    From
    (Art. 113 second subparagraph)
    Legal practice
    Reaches legal-AI vendors or public bodies — Medium for legal-AI real-world testing documentation.
    See
    Art. 60

Cite

Regulation (EU) 2024/1689, Article 61 (Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes), as amended by Regulation (EU) 2026/1744, consolidated text of 27 July 2026, https://eur-lex.europa.eu/eli/reg/2024/1689/2026-07-27/eng#art_61 — text © European Union; only the Official Journal is authentic. Coding: SafeLegalAI (published by Cognesio LLP), "EU AI Act, structured", safelegalai.com/regulation/eu-ai-act/article-61, accessed 2026-09-08, CC BY 4.0.