Article 61 of Regulation (EU) 2024/1689 — Informed consent in real-world testing. Official text, practical interpretation, key obligations and compliance implications.
Article 61 sets the consent floor for testing high-risk AI systems in real-world conditions under Article 60: no subject participates without freely given, informed consent. It transposes a clinical-trials instinct into AI testing.
Official Text Summary
Before taking part in real-world testing under Article 60, subjects must give freely given informed consent, obtained after they receive concise, clear, relevant and understandable information about the nature and objectives of the testing, the conditions of participation and its expected duration, their rights and the guarantees attached — notably the right to refuse to participate and the right to withdraw at any time without giving reasons and without suffering any detriment — and the arrangements for requesting reversal or disregard of the system's outputs. Consent must be dated and documented, and a copy given to the subject or their legal representative.
Key Obligations
- Consent must be obtained before any participation, after concise, clear, relevant and understandable information on the testing's nature, objectives, conditions, expected duration and the subject's rights
- Subjects may refuse or withdraw at any time without justification and without any detriment; withdrawal only stops future participation
- Consent must be dated and documented, and a copy given to the subject or their legal representative
Compliance Timeline
Applies from 2 August 2026; the 2026 Digital Omnibus deferred the substantive high-risk obligations (Annex III to 2 December 2027, Annex I to 2 August 2028) but did not move this provision.
Official AI Act Compliance Deadline Calendar
Updated · Sources: Regulation (EU) 2024/1689 and the 2026 Digital Omnibus on AI.
| Obligation | Applies to | Original date | New date | Status | Countdown | Legal basis |
|---|---|---|---|---|---|---|
| Prohibited Practices (Art. 5) | All providers and deployers | active | — | AI Act Art. 5 | ||
| GPAI Rules (Chapter 5) | GPAI model providers | active | — | AI Act Art. 51-56 | ||
| Commission Enforcement Powers over GPAI | GPAI model providers | active | — | AI Act Art. 88-94, 101 | ||
| Transparency Obligations (Art. 50) | Providers and deployers of chatbots, generative, emotion recognition systems | active | — | AI Act Art. 50 | ||
| New Art. 5 Prohibition (CSAM / non-consensual intimate imagery) | Providers and deployers of generative AI systems | active | — | AI Omnibus 2026 Art. 5 | ||
| AI-Generated Content Marking (pre-existing systems) | Providers of generative AI systems on the market before 2 Aug 2026 | active | — | AI Act Art. 50(2) — transitional | ||
| Regulatory Sandboxes | National competent authorities | deferred | — | AI Omnibus 2026 Art. 57 | ||
| High-risk AI — Annex III (standalone) | Providers of standalone Annex III systems | deferred | — | AI Omnibus 2026 Art. 6(2) | ||
| High-risk AI — Annex I (embedded) | AI embedded in Annex I regulated products | deferred | — | AI Omnibus 2026 Art. 6(1) |
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AI Act meets DORA and NIS2
Is your organisation subject to both the AI Act and DORA? The two regulations intersect on the operational resilience of financial AI systems. Our sister site regulation-dora.eu covers DORA in depth — including what the AI Act adds on top of an existing DORA programme.
The AI Act for financial institutions ↗ Explore regulation-dora.eu ↗Frequently Asked Questions
Yes, at any time, without justification and without detriment. Withdrawal ends future participation but does not require deleting what was lawfully collected up to that point — data protection rules govern the collected data.
Article 61 consent is a testing-participation safeguard, not a legal basis for data processing. Where personal data is processed during testing, a valid GDPR basis is needed separately, and both sets of information duties must be satisfied.
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