EU AI Act Art.61: Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
Article 61 of the EU AI Act binds the operator (see the article). It requires Before a subject participates in testing in real world conditions under Art. This page states what it requires, who it binds and the evidence to keep. Browsing is free; the conformance kit is USD 499.
Specifics
| Instrument | Regulation (EU) 2024/1689 (the EU AI Act), as amended by Regulation (EU) 2026/1744 |
|---|---|
| Article | Art.61 |
| Binds | Operator (see the article) |
| Group | Innovation Measures |
| Evidence items | 5 |
| Linked NIST AI RMF controls | 1 |
| Linked ISO/IEC 42001 controls | 0 |
| Last updated |
Who does Art.61 bind?
The article binds the operator (see the article). The Act places each duty on a named party in the value chain, so a system can carry a provider duty and a deployer duty at once. Confirm your own position against the text; this page names the party, it does not rule on your facts.
Application is set by Article 113, as amended by Regulation (EU) 2026/1744; check the timeline. See the full timeline.
What does Art.61 require?
Before a subject participates in testing in real world conditions under Art.60, freely given informed consent must be obtained after the subject has been duly informed, in concise, clear, relevant and understandable terms, of the nature and objectives of the testing and the possible inconvenience of participating; the conditions under which the testing will be conducted, including the expected duration of their participation; their rights and the guarantees regarding their participation, in particular the right to refuse and the right to withdraw at any time without any resulting detriment and without giving reasons; the arrangements for requesting the reversal or disregarding of the system's predictions, recommendations or decisions; and the Union-wide unique single identification number of the testing together with contact details for the provider or its legal representative. The consent must be dated and documented, and a copy given to the subject or their legal representative.
This is our plain-language statement of the article, not the text of the regulation. Read the article: Art.61 (Regulation (EU) 2024/1689 on EUR-Lex).
What evidence should we keep for Art.61?
| Category | Evidence to keep |
|---|---|
| Informed consent | The consent information sheet covering all five Art.61(1) points in plain language |
| Informed consent | Dated, documented consent records for every subject of the testing |
| Informed consent | Evidence a copy was given to each subject or their legal representative |
| Informed consent | The reversal request arrangements as communicated to subjects, and records of any request made under them |
| Informed consent | A readability or comprehension check on the consent material, since the standard is concise, clear, relevant and understandable |
What does a linked control mean here?
A linked control is a NIST AI RMF or ISO/IEC 42001 control that the held rule set records as a topical match, with a confidence and a one-line reason. It does not establish that meeting one requirement satisfies the other, it is not legal advice, and it is not certification. Where no control is recorded, the page says so and does not guess. Sources: the NIST AI RMF and ISO/IEC 42001.
Which NIST AI RMF controls line up with Art.61?
1 control in the held rule set is recorded as a topical match for this obligation, each with its confidence and reason.
| Control | NIST AI RMF | Confidence |
|---|---|---|
AIRMF-MS-2.2 | Evaluations involving human subjects meet applicable requirements including human subject protection and are representative of the relevant population Freely given informed consent after full disclosure, with a right to withdraw, is human subject protection. | high |
Which ISO/IEC 42001 controls line up with Art.61?
No ISO/IEC 42001 control is recorded as a match for this obligation in the held rule set. It is left unlinked and marked, never guessed.
What does the conformance kit add for Art.61?
The kit renders this obligation into your own role checklist with the evidence register, the linked controls and a CSV export, for USD 499 one off. See what is in the kit or open it.