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Recitals
Chapter I: General Provisions
Chapter II: Prohibited AI Practices
Chapter III: High-Risk AI Systems

Section 1: Classification of AI Systems as High-Risk

Section 2: Requirements for High-Risk AI Systems

Section 3: Obligations of Providers and Deployers of High-Risk AI Systems and Other Parties

Section 4: Notifying Authorities and Notified Bodies

Section 5: Standards, Conformity Assessment, Certificates, Registration

Chapter IV: Transparency Obligations for Providers and Deployers of Certain AI Systems
Chapter V: General-Purpose AI Models
Chapter VI: Measures in Support of Innovation
Chapter VII: Governance
Chapter VIII: EU Database for High-Risk AI Systems
Chapter IX: Post-Market Monitoring, Information Sharing and Market Surveillance

Section 1: Post-Market Monitoring

Section 2: Sharing of Information on Serious Incidents

Section 3: Enforcement

Section 4: Remedies

Section 5: Supervision, Investigation, Enforcement and Monitoring in Respect of Providers of General-Purpose AI Models

Chapter X: Codes of Conduct and Guidelines
Chapter XI: Delegation of Power and Committee Procedure
Chapter XII: Penalties
Chapter XIII: Final Provisions
Annexes
  • Chapter VI: Measures in Support of Innovation

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

Summary

The article specifies the requirements for obtaining informed consent from participants in real-world testing of high-risk AI systems. Participants must be clearly informed about the testing's nature, objectives, duration, their rights, and how to reverse AI decisions. Consent must be freely given prior to their participation in testing, which should be documented, dated, and a copy provided to participants.

The summaries are meant to provide helpful explanation but are not legal binding.

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.

Relevant recitals