Artificial Intelligence Act·Article 61
Informed consent to participate in testing in real world conditions outside AI regulatory sandboxes
Applies since August 2, 2026· Art. 113
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:
- the nature and objectives of the testing in real world conditions and the possible inconvenience that may be linked to their participation;
- the conditions under which the testing in real world conditions is to be conducted, including the expected duration of the subject or subjects’ participation;
- 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;
- the arrangements for requesting the reversal or the disregarding of the predictions, recommendations or decisions of the AI system;
- 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.
The informed consent shall be dated and documented and a copy shall be given to the subjects of testing or their legal representative.