Chapter VI · MEASURES IN SUPPORT OF INNOVATION
Article 61 — Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
▼ Primary text, verbatim. Our annotations appear below, visibly separated.
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:
(a) the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
(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;
(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;
(d) the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
(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.
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex.
What this means for you
In your terms · Real-world testing outside sandboxes
Test cohorts and their consent state are data your system has to track.
In your terms · Real-world testing outside sandboxes
A live test can be ordered to stop. Article 60(7) requires immediate mitigation on a serious incident, suspension or termination failing that, and a procedure for prompt recall: the watch on the test and the paths to halt and pull it back are operational work that exists before recruitment starts.
- Test monitoring with a halt path
- Prompt-recall procedure
In your terms · Real-world testing outside sandboxes
A pilot with real users of a would-be high-risk system is a regulated activity: the plan and the consent flow are launch blockers, not afterthoughts.
- Real-world testing plan
- Informed-consent flow for test subjects
Failure smells likeTesting in the field started because it was the fastest way to learn, and the plan, the approval and the consent were left as things to sort out later.
In your terms · Real-world testing outside sandboxes
Whether your pilot is inside or outside this regime is a scoping call to make before recruitment starts.
- Testing-regime scope determination
Obligations derived from this article
If you would rather not read the law
The basics page explains the Regulation's own categories in order: scope, role, tier, date. The engineering view groups the obligations by the platform capability they demand.