EU AI Act Art.60: Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes
Article 60 of the EU AI Act binds the operator (see the article). It requires A provider or prospective provider testing an Annex III high-risk AI system in real world conditions outside a sandbox may. This page states what it requires, who it binds and the evidence to keep. Browsing is free; the conformance kit is USD 499.
Specifics
| Instrument | Regulation (EU) 2024/1689 (the EU AI Act), as amended by Regulation (EU) 2026/1744 |
|---|---|
| Article | Art.60 |
| Binds | Operator (see the article) |
| Group | Innovation Measures |
| Evidence items | 7 |
| Linked NIST AI RMF controls | 2 |
| Linked ISO/IEC 42001 controls | 0 |
| Last updated |
Who does Art.60 bind?
The article binds the operator (see the article). The Act places each duty on a named party in the value chain, so a system can carry a provider duty and a deployer duty at once. Confirm your own position against the text; this page names the party, it does not rule on your facts.
Application is set by Article 113, as amended by Regulation (EU) 2026/1744; check the timeline. See the full timeline.
What does Art.60 require?
A provider or prospective provider testing an Annex III high-risk AI system in real world conditions outside a sandbox may do so only where every Art.60(4) condition is met: a real-world testing plan has been drawn up and submitted to the market surveillance authority of the Member State where the testing takes place; that authority has approved the testing and the plan, approval being understood as given after thirty days of silence unless national law requires an express authorisation; the testing has been registered with a Union-wide unique single identification number and the Annex IX information, in the secure non-public section for law enforcement, migration, asylum and border control systems; the provider is established in the Union or has appointed a Union legal representative; data transferred to third countries is covered by applicable Union safeguards; the testing lasts no longer than necessary and no more than six months, extendable once by six months on prior notification with an explanation; subjects belonging to vulnerable groups are appropriately protected; co-operating deployers are informed of all relevant aspects, given the Art.13 instructions for use, and bound by an agreement setting out roles and responsibilities; the subjects have given informed consent under Art.61, save in the narrow law enforcement case where the testing and its outcome must have no negative effect and personal data must be deleted afterwards; the testing is effectively overseen by suitably qualified persons with the capacity, training and authority to act; and the system's predictions, recommendations or decisions can be effectively reversed and disregarded. Subjects may withdraw at any time without detriment or justification and may require the immediate permanent deletion of their personal data, and any serious incident during the testing must be reported under Art.73.
This is our plain-language statement of the article, not the text of the regulation. Read the article: Art.60 (Regulation (EU) 2024/1689 on EUR-Lex).
What evidence should we keep for Art.60?
| Category | Evidence to keep |
|---|---|
| Real-world testing | The real-world testing plan and evidence of its submission to and approval by the market surveillance authority |
| Real-world testing | The registration record carrying the Union-wide unique single identification number and the Annex IX information |
| Real-world testing | The written agreement with each co-operating deployer setting out roles and responsibilities |
| Real-world testing | Records showing the testing duration against the six month limit, with the prior notification and explanation for any extension |
| Real-world testing | Evidence of qualified oversight, naming who oversaw the testing and the authority they held to intervene |
| Real-world testing | A demonstrated reversal mechanism showing predictions, recommendations or decisions can be effectively reversed and disregarded |
| Real-world testing | Withdrawal and deletion records for any subject who withdrew |
What does a linked control mean here?
A linked control is a NIST AI RMF or ISO/IEC 42001 control that the held rule set records as a topical match, with a confidence and a one-line reason. It does not establish that meeting one requirement satisfies the other, it is not legal advice, and it is not certification. Where no control is recorded, the page says so and does not guess. Sources: the NIST AI RMF and ISO/IEC 42001.
Which NIST AI RMF controls line up with Art.60?
2 controls in the held rule set is recorded as a topical match for this obligation, each with its confidence and reason.
| Control | NIST AI RMF | Confidence |
|---|---|---|
AIRMF-MS-2.3 | AI system performance or assurance criteria are measured qualitatively or quantitatively and demonstrated for conditions similar to deployment settings, and measures are documented Testing in real world conditions under an approved plan is measurement under deployment-like conditions. | high |
AIRMF-MS-4.1 | Measurement approaches for identifying AI risks are connected to deployment contexts and informed through consultation with domain experts and other end users, and approaches are documented A real-world testing plan approved by the market surveillance authority ties measurement to the deployment context. | high |
Which ISO/IEC 42001 controls line up with Art.60?
No ISO/IEC 42001 control is recorded as a match for this obligation in the held rule set. It is left unlinked and marked, never guessed.
What does the conformance kit add for Art.60?
The kit renders this obligation into your own role checklist with the evidence register, the linked controls and a CSV export, for USD 499 one off. See what is in the kit or open it.