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ObligationApplicablev1.0.0

Article 60: testing in real world conditions outside a sandbox

If you want to test an Annex III high-risk AI system with real people and real outcomes before placing it on the market, a full regime applies: a plan, prior approval by the market surveillance authority, registration, informed consent and a maximum duration.

The official source remains authoritative. This is general information about obligations and not legal advice. See this object on the map

Address and citation

This object has an address of its own that is never renamed or reused. Store the identifier in your own file, not the title or the link.

Identifier
praxikon:eu:ai-act:obligation:article-60-real-world-testing
Payload hash (sha256)
6306b9a0abce6764b0c4ebf4968aacf23cd2483dba7b750f1cb18716886ea751

Citation line

Praxikon, "Article 60: testing in real world conditions outside a sandbox", praxikon:eu:ai-act:obligation:article-60-real-world-testing@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-08-14T00:00:00.000Z, sha256 6306b9a0abce6764b0c4ebf4968aacf23cd2483dba7b750f1cb18716886ea751
Version
1.0.0
Legal time (effective_at)
8 August 2026
Knowledge time (known_at)
8 August 2026
Closed on
Not closed
Application date
2 August 2026
Topics
innovation

Review status: Placed against the official source (8 August 2026). Next check due by 4 February 2027. The check date is the knowledge date of this version; no later recheck has been recorded.

Who must act and who is affected

On an obligation the addressee is recorded separately from the party that is merely affected. That difference decides who a supervisory authority addresses and who has work to do without the duty resting on them.

Duty holder

Affected actor

  • Deployerpraxikon:eu:ai-act:actor:deployer

Oversight

Evidence owner

What this object links to

Every relation appears below as a path: from the source with its locator, through the conditions and exceptions of the object carrying the relation, to the consequence. A locator belongs to a statement in the data and not to a relation, so the source is the source anchor of the carrying object.

Who carries the duty

1 of 1 shown

The duty rests on this role. A supervisory authority addresses this role when it is not met.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22.
    • ExceptionArticle 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

Who is affected without being the addressee

1 of 1 shown

This role is practically affected without being the addressee: it receives the information, has to cooperate, or absorbs the consequences in its own process.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22.
    • ExceptionArticle 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

    • ActorDeployer

      praxikon:eu:ai-act:actor:deployer

Who supervises this

1 of 1 shown

This role supervises and receives the notifications. It is the institutional role, not the national body that fills it.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22.
    • ExceptionArticle 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

Who owns the evidence

1 of 1 shown

This duty holder creates, maintains and can produce the evidence.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22.
    • ExceptionArticle 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What has to be done

1 of 1 shown

This is what concretely has to be done under the obligation.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22.
    • ExceptionArticle 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What has to be recorded

1 of 1 shown

This is what has to be in the file to show that the action was carried out.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22.
    • ExceptionArticle 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What keeps it in place

1 of 1 shown

This is what keeps compliance in place over time, periodic or event-driven.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22.
    • ExceptionArticle 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

Public tools

1 of 1 shown

This is the public route a reader can actually use.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22.
    • ExceptionArticle 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What points at this object

Objects hanging off this obligation

4 of 4 shown

The object belongs to this obligation. The source line it hangs off sits there.

  1. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies before you start testing in real world conditions outside a sandbox. All conditions in Article 60(4) must be met cumulatively; it is not a menu.
    • ExceptionTacit approval after 30 days applies only where national law provides for it. Where national law does not, express authorisation remains required. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, critical infrastructure, a different route applies: Article 49(5) requires registration at national level.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Relation recorded on: Submit the testing plan, obtain approval and register the test

    Consequence

  2. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies throughout the entire duration of the testing in real world conditions, and on its completion, suspension or termination.
    • ExceptionThe Regulation provides no exception to the duty to report a serious incident or to the inspection powers. The reporting route itself runs through Article 73, which governs the deadlines and the manner of reporting.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Relation recorded on: Oversight during the test, incident reporting and recall procedure

    Consequence

  3. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allApplies to every natural person who is a subject of testing in real world conditions under Article 60, prior to their participation.
    • ExceptionArticle 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the AI system from being tested, testing may proceed without consent, provided that the testing and its outcome have no negative effect on the subjects and that their personal data are deleted after the test is performed. Outside that specific context there is no exception to consent.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Relation recorded on: Dated and documented informed consent of test subjects

    Consequence

  4. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 60(1)-(4), Article 60(9), Article 113

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Full text of Article 60

    Consequence

What this object states

Official fact

Attributable to a named primary source, with a locator. Where they differ, the official source prevails.

  • Article 60(1) provides that testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes may be conducted by providers or prospective providers of high-risk AI systems listed in Annex III, in accordance with that Article and the real-world testing plan, without prejudice to the prohibitions under Article 5. The Commission specifies the detailed elements of that plan by implementing act. The third subparagraph of paragraph 1 provides that the paragraph is without prejudice to Union or national law on the testing in real world conditions of high-risk AI systems related to products covered by the Union harmonisation legislation listed in Annex I. Article 60(2) allows providers or prospective providers to test at any time before placing on the market or putting into service, on their own or in partnership with one or more deployers or prospective deployers. Article 60(3) provides that such testing is without prejudice to any ethical review required by Union or national law. Article 60(4), point (f), caps the duration: no longer than necessary to achieve its objectives and in any case no longer than six months, which may be extended by an additional six months subject to prior notification to the market surveillance authority with an explanation of the need. Article 60(4), point (g), requires that subjects belonging to vulnerable groups due to age or disability are appropriately protected. Article 60(9) expressly states that the provider or prospective provider remains fully subject to applicable Union and national law on any damage caused in the course of their testing in real world conditions. Chapter VI, which contains Article 60, is not among the exceptions in Article 113 and applies since 2 August 2026.

    • Locator: Article 60(1)-(4), Article 60(9), Article 113praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

Our interpretation

Our own reading. It can change without the law changing, and it is not the position of a supervisory authority.

  • Many organisations call what they do a pilot and assume that keeps them outside the Regulation. Article 60 shows that this does not hold once you test an Annex III system in real world conditions with real people and real outcomes. A full regime then applies: a plan, prior approval, registration with a Union-wide unique single identification number, informed consent, and a hard six-month clock with a maximum six-month extension. The heaviest requirement in practice is Article 60(4), point (k): the predictions, recommendations or decisions of the system must be capable of being effectively reversed and disregarded. If you are testing a selection, scoring or triage system whose output feeds straight into the workflow with nobody able to reverse it, your design does not qualify, however careful your consent form is. Note the timing too, because it is commercially interesting. Chapter VI applies since 2 August 2026, while the core obligations for standalone Annex III systems only apply from 2 December 2027. The testing route is therefore open before the requirements themselves bite, and that is exactly the window in which to validate your design rather than rebuild it later. Finally, Article 60(3) leaves any ethical review required under other law fully in place, and Article 60(9) expressly states that you remain fully subject to the applicable law on damage caused during the testing.

    • Locator: Article 60(1)-(4), Article 60(9), Article 113praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

Recommended step

A practical step we consider appropriate. Not an obligation following from the Regulation.

  • Inventory which running or planned trials are in fact real-world testing: real users, real data, outputs that feed into the workflow. Test those first against Article 60(4), point (k): can the output genuinely be reversed and disregarded? If not, redesign the trial before you submit anything. Then choose deliberately between two routes: supervised testing inside a sandbox under Article 57(5) and Article 58(4), or outside a sandbox under Article 60. Plan the six months realistically and decide in advance at which point you will request an extension, since that requires prior notification with a reasoned explanation. Check whether an ethical review is mandatory in your domain and start it in parallel, because Article 60(3) does not exempt you from it.

    • Locator: Article 60(1)-(4), Article 60(9), Article 113praxikon:eu:ai-act:source:reg-eu-2024-1689Open official source

When this applies

  1. 1Applies where you are a provider or prospective provider of an Annex III high-risk AI system and you want to test it in real world conditions outside an AI regulatory sandbox, before placing it on the market or putting it into service. If you are established outside the Union, Article 60(4), point (d), requires you to appoint a legal representative established in the Union; that is a different figure from the authorised representative under Article 22.

When this does not apply

  • Article 60(1), third subparagraph, leaves Union and national law on real-world testing of high-risk systems related to products under the Annex I harmonisation legislation unaffected. Article 60(4), point (i), contains a law enforcement carve-out: where seeking informed consent would prevent the system from being tested, testing may proceed without consent, provided the testing and its outcome have no negative effect on the subjects and their personal data are deleted after the test. For the systems referred to in Annex III, points 1, 6 and 7, in law enforcement, migration, asylum and border control, registration runs through the secure non-public section of the EU database under Article 49(4), point (d). For the systems referred to in Annex III, point 2, Article 49(5) requires registration at national level.

Referring to this object

Citation block

Copy this reference into your advice, article or file. The identifier, the version and the hash keep the statement findable later, even once the dataset has moved on.

Reference

Praxikon, "Article 60: testing in real world conditions outside a sandbox",
praxikon:eu:ai-act:obligation:article-60-real-world-testing@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0),
effective_at 2026-08-08T00:00:00.000Z, known_at 2026-08-08T00:00:00.000Z,
sha256 6306b9a0abce6764b0c4ebf4968aacf23cd2483dba7b750f1cb18716886ea751,
https://www.praxikon.com/en/verkenner/obligation/article-60-real-world-testing
(https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-60-real-world-testing&effective_at=2026-08-08&known_at=2026-08-08&lang=en, accessed 2026-08-25)

Short form

praxikon:eu:ai-act:obligation:article-60-real-world-testing@1.0.0 (sha256 6306b9a0)

BibTeX

@misc{praxikon-eu-ai-act-obligation-article-60-real-world-testing-1-0-0,
  author       = {{Praxikon}},
  title        = {Article 60: testing in real world conditions outside a sandbox},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:obligation:article-60-real-world-testing},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.1.0, schema 1.4.0},
  note         = {effective_at 2026-08-08T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 6306b9a0abce6764b0c4ebf4968aacf23cd2483dba7b750f1cb18716886ea751},
  url          = {https://www.praxikon.com/en/verkenner/obligation/article-60-real-world-testing},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:obligation:article-60-real-world-testing@1.0.0",
    "type": "dataset",
    "title": "Article 60: testing in real world conditions outside a sandbox",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:obligation:article-60-real-world-testing",
    "URL": "https://www.praxikon.com/en/verkenner/obligation/article-60-real-world-testing",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          8
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          8,
          25
        ]
      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0; schema 1.4.0; effective_at 2026-08-08T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 6306b9a0abce6764b0c4ebf4968aacf23cd2483dba7b750f1cb18716886ea751; retrieved_from https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-60-real-world-testing&effective_at=2026-08-08&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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