Article 60 — Testing of high-risk AI systems in real-world conditions outside AI regulatory sandboxes (EU AI Act)

Article 60 of Regulation (EU) 2024/1689 — Testing of high-risk AI systems in real-world conditions outside AI regulatory sandboxes. Official text, practical interpretation, key obligations and compliance implications.

Official Text Summary

Article 60 of Regulation (EU) 2024/1689 establishes the conditions under which providers and prospective providers of high-risk AI systems may conduct testing in real-world conditions outside the structured framework of AI regulatory sandboxes established under Articles 57 to 59. This provision recognises that meaningful evaluation of high-risk AI systems often requires exposure to genuine operational environments, while maintaining safeguards commensurate with the risks involved.

The article requires that testing outside sandboxes be carried out only where a set of cumulative conditions are met. The provider or prospective provider must submit a notification to the competent national authority at least 30 days prior to commencing testing. The notification must include a test plan describing the scope, duration, geographical area, categories of persons involved, and the risk mitigation measures in place.

Informed consent of subjects is a central requirement. Where the AI system interacts with or makes decisions affecting identifiable natural persons, those persons must be informed of their participation and must consent explicitly, unless applicable sectoral law provides otherwise. Testing must not exceed what is strictly necessary to achieve the stated objectives, and must not expose subjects to unacceptable risk or harm.

The article further requires that the testing be conducted under the supervision of the provider, that results be recorded, and that serious incidents encountered during testing be reported to the competent authority. Member States retain the ability to authorise or refuse testing activities in their territory and may impose additional conditions.

What This Means in Practice

Article 60 is primarily relevant to organisations developing or deploying high-risk AI systems — as defined under Article 6 and Annex III of the Regulation — who need to validate system performance or safety properties in genuine operational settings before or alongside formal conformity assessment. This includes, for example, a hospital piloting an AI-assisted diagnostic tool in a live clinical environment, or a financial institution testing a creditworthiness model with real applicants outside a controlled sandbox.

In practice, compliance means establishing an internal process for managing real-world tests that mirrors the obligations of the article. Before any test begins, the organisation must prepare a structured test plan, verify that all consent mechanisms are in place, and lodge the required notification with the competent authority at least 30 days in advance — leaving adequate time for the authority to raise objections or impose conditions.

During the test, the organisation must maintain active human oversight, document all material incidents, and be prepared to suspend testing immediately if risks exceed anticipated levels. Data collected during testing remains subject to applicable GDPR obligations, and the processing of special categories of data requires a specific legal basis.

Organisations should also ensure their contracts with deployers or third-party test operators clearly allocate responsibility for compliance with Article 60 conditions, since the obligation sits primarily with the provider or prospective provider regardless of who physically conducts the test. Internal governance frameworks — including a designated responsible person and a documented risk register for the test — are strongly advisable.

Key Obligations

• Advance notification: Submit a test plan to the relevant national competent authority at least 30 days before real-world testing commences, covering scope, duration, location, subject categories, and risk mitigation measures.
• Informed consent: Obtain explicit informed consent from all natural persons involved in or affected by the testing, and inform them of their unconditional right to withdraw at any time without detriment.
• Risk proportionality: Ensure that testing activities do not exceed what is strictly necessary for the stated objective and do not expose subjects or third parties to risks that outweigh the expected benefits.
• Supervision and documentation: Maintain active oversight of the test, keep records of the test plan, results, and any deviations or incidents encountered throughout the testing period.
• Incident reporting: Report without undue delay any serious incident that occurs during real-world testing to the competent authority, and take immediate corrective action to mitigate harm.
• EU database registration: Register the real-world testing activity in the EU database for high-risk AI systems established under Article 71, prior to commencing testing.

Relationship to Other Articles

Article 60 is part of Title VI (Measures in Support of Innovation) and should be read alongside Articles 57 to 59, which establish the primary framework for AI regulatory sandboxes. Article 60 functions as a complementary pathway for testing that does not take place within a formal sandbox, but it does not replace or lower the substantive safety and transparency obligations that apply to high-risk AI systems under Title III (particularly Articles 8 to 15 on provider obligations, risk management, and technical documentation).

The consent and data protection requirements of Article 60 intersect directly with Regulation (EU) 2016/679 (GDPR), particularly Articles 6, 9, and 22 on lawful processing and automated decision-making. Article 60 also connects to Article 71 on the EU database, which governs registration obligations, and to Article 73 on market surveillance, since competent authorities may inspect real-world tests. Providers should additionally consider Article 26 on obligations of deployers, as real-world testing frequently involves deployer-side infrastructure and data.

Compliance Timeline

The EU AI Act entered into force on 1 August 2024, twenty days after its publication in the Official Journal of the European Union. Its provisions apply in phases:

• 2 February 2025 — Prohibitions on unacceptable-risk AI practices (Article 5) became applicable.
• 2 August 2025 — Provisions on general-purpose AI models (Title III, Chapter 3, Articles 51 to 56) and governance obligations (Title VI and VIII in part) became applicable. The regulatory sandbox framework under Articles 57 to 59 also became applicable from this date.
• 2 August 2026 — The general application date for most remaining provisions, including Article 60. From this date, providers and prospective providers of high-risk AI systems wishing to conduct real-world testing outside sandboxes must comply fully with the notification, consent, documentation, and incident reporting obligations established by this article.
• 2 August 2027 — Extended deadline for high-risk AI systems falling under Annex III, point 2 (AI systems in existing products already subject to Union harmonisation legislation listed in Annex I), giving affected sectors additional time to align with conformity assessment and operational requirements.

Organisations planning real-world testing programmes should begin designing compliant test governance frameworks and notification procedures well in advance of the 2 August 2026 date to avoid delays when the obligation becomes enforceable.