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Regulation Tracker / EU AI Act / Chapter VI

Article 60
Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes

Chapter VI — AI regulatory sandboxes. 21 distinct duties, powers or definitions are coded from this article, applying from 2026-08-02. 1 reaches legal practice directly.

Amended by Regulation (EU) 2026/1744 (Digital Omnibus on AI), in force 2026-07-27 — about 96 words changed. The text below is the consolidated version of 27 July 2026; the 2024 text and the amending regulation are on EUR-Lex.

official text: EUR-Lex (consolidated 27 Jul 2026) · text © European Union (Decision 2011/833/EU) · coding CC BY 4.0 · data: obligations.json · Hugging Face · GitHub

The text

1. 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 or covered by Union harmonisation legislation listed in Section A of Annex I, in accordance with this Article and the real-world testing plan referred to in this Article, without prejudice to the prohibitions under Article 5.

2. Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III or covered by Union harmonisation legislation listed in Section A of Annex I in real world conditions at any time before the placing on the market or the putting into service of the high-risk AI system on their own or in partnership with one or more deployers or prospective deployers.

3. The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to any ethical review that is required by Union or national law.

4. Providers or prospective providers may conduct the testing in real world conditions only where all of the following conditions are met:

  1. (a)the provider or prospective provider has drawn up a real-world testing plan and submitted it to the market surveillance authority in the Member State where the testing in real world conditions is to be conducted;
  2. (b)the market surveillance authority in the Member State where the testing in real world conditions is to be conducted has approved the testing in real world conditions and the real-world testing plan; where the market surveillance authority has not provided an answer within 30 days, the testing in real world conditions and the real-world testing plan shall be understood to have been approved; where national law does not provide for a tacit approval, the testing in real world conditions shall remain subject to an authorisation;
  3. (c)the provider or prospective provider, with the exception of providers or prospective providers of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, and high-risk AI systems referred to in point 2 of Annex III has registered the testing in real world conditions in accordance with Article 71(4) with a Union-wide unique single identification number and with the information specified in Annex IX; the provider or prospective provider of high-risk AI systems referred to in points 1, 6 and 7 of Annex III in the areas of law enforcement, migration, asylum and border control management, has registered the testing in real-world conditions in the secure non-public section of the EU database according to Article 49(4), point (d), with a Union-wide unique single identification number and with the information specified therein; the provider or prospective provider of high-risk AI systems referred to in point 2 of Annex III has registered the testing in real-world conditions in accordance with Article 49(5);
  4. (d)the provider or prospective provider conducting the testing in real world conditions is established in the Union or has appointed a legal representative who is established in the Union;
  5. (e)data collected and processed for the purpose of the testing in real world conditions shall be transferred to third countries only provided that appropriate and applicable safeguards under Union law are implemented;
  6. (f)the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not longer than six months, which may be extended for an additional period of six months, subject to prior notification by the provider or prospective provider to the market surveillance authority, accompanied by an explanation of the need for such an extension;
  7. (g)the subjects of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or disability, are appropriately protected;
  8. (h)where a provider or prospective provider organises the testing in real world conditions in cooperation with one or more deployers or prospective deployers, the latter have been informed of all aspects of the testing that are relevant to their decision to participate, and given the relevant instructions for use of the AI system referred to in Article 13; the provider or prospective provider and the deployer or prospective deployer shall conclude an agreement specifying their roles and responsibilities with a view to ensuring compliance with the provisions for testing in real world conditions under this Regulation and under other applicable Union and national law;
  9. (i)the subjects of the testing in real world conditions have given informed consent in accordance with Article 61, or in the case of law enforcement, where the seeking of informed consent would prevent the AI system from being tested, the testing itself and the outcome of the testing in the real world conditions shall not have any negative effect on the subjects, and their personal data shall be deleted after the test is performed;
  10. (j)the testing in real world conditions is effectively overseen by the provider or prospective provider, as well as by deployers or prospective deployers through persons who are suitably qualified in the relevant field and have the necessary capacity, training and authority to perform their tasks;
  11. (k)the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded.

5. Any subjects of the testing in real world conditions, or their legally designated representative, as appropriate, may, without any resulting detriment and without having to provide any justification, withdraw from the testing at any time by revoking their informed consent and may request the immediate and permanent deletion of their personal data. The withdrawal of the informed consent shall not affect the activities already carried out.

6. In accordance with Article 75, Member States shall confer on their market surveillance authorities the powers of requiring providers and prospective providers to provide information, of carrying out unannounced remote or on-site inspections, and of performing checks on the conduct of the testing in real world conditions and the related high-risk AI systems. Market surveillance authorities shall use those powers to ensure the safe development of testing in real world conditions.

7. Any serious incident identified in the course of the testing in real world conditions shall be reported to the national market surveillance authority in accordance with Article 73. The provider or prospective provider shall adopt immediate mitigation measures or, failing that, shall suspend the testing in real world conditions until such mitigation takes place, or otherwise terminate it. The provider or prospective provider shall establish a procedure for the prompt recall of the AI system upon such termination of the testing in real world conditions.

8. Providers or prospective providers shall notify the national market surveillance authority in the Member State where the testing in real world conditions is to be conducted of the suspension or termination of the testing in real world conditions and of the final outcomes.

9. The provider or prospective provider shall be liable under applicable Union and national liability law for any damage caused in the course of their testing in real world conditions.

What it requires, coded

SafeLegalAI's reading of each duty in this article: who, what, from when, under which fine tier, and whether it reaches a firm, chambers, court or legal-AI vendor. Descriptive, not advice; the quoted words are the Regulation's.

  1. Art. 60(1)Scope or definitionHigh-risk

    Providers or prospective providers may conduct real-world testing of Annex III or Annex I Section A high-risk AI systems outside sandboxes only under Article 60 and the real-world testing plan, without prejudice to Article 5 prohibitions.

    "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 or covered by Union harmonisation legislation listed in Section A of Annex I"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers testing Annex III high-risk systems outside sandboxes.
    See
    Annex III · Annex I Section A · Art. 5

  2. Art. 60(2)Support measureHigh-risk

    Providers or prospective providers may conduct pre-market real-world testing of covered high-risk AI systems on their own or with deployers or prospective deployers.

    "Providers or prospective providers may conduct testing of high-risk AI systems referred to in Annex III or covered by Union harmonisation legislation listed in Section A of Annex I in real world conditions at any time before the placing on the market"
    Who
    Provider, Deployer
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers and participating deployers in pre-market tests of high-risk systems.
    See
    Annex III · Annex I Section A

  3. Art. 60(3)Scope or definitionHigh-risk

    Real-world testing under Article 60 does not displace any ethical review required by Union or national law.

    "The testing of high-risk AI systems in real world conditions under this Article shall be without prejudice to any ethical review that is required by Union or national law"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant where legal-AI testing involving people, courts or public services triggers ethical review.
    See
    Union or national ethical-review law

  4. Art. 60(4) (a)DocumentationHigh-risk

    A provider or prospective provider may conduct real-world testing only after drawing up a real-world testing plan and submitting it to the market surveillance authority in the Member State where testing will occur.

    "the provider or prospective provider has drawn up a real-world testing plan and submitted it to the market surveillance authority in the Member State where the testing in real world conditions is to be conducted"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers planning high-risk real-world tests.
    See
    Market surveillance authority

  5. Art. 60(4) (b)Conformity assessmentHigh-risk

    Real-world testing may proceed only when the market surveillance authority approves the testing and plan, or where applicable is deemed to have approved after 30 days; national law may require express authorisation.

    "the market surveillance authority in the Member State where the testing in real world conditions is to be conducted has approved the testing in real world conditions and the real-world testing plan"
    Who
    Provider, Market surveillance authority
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers needing authority approval for high-risk real-world tests.
    See
    Market surveillance authority

  6. Art. 60(4) (c)RegistrationHigh-risk

    The provider or prospective provider must register real-world testing with the required Union-wide identification number and information in the appropriate EU database, secure non-public database section, or national register depending on the system category.

    "the provider or prospective provider, with the exception of providers or prospective providers of high-risk AI systems referred to in points 1, 6 and 7 of Annex III"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers registering high-risk real-world tests.
    See
    Art. 71(4) · Art. 49(4) · Art. 49(5) · Annex IX

  7. Art. 60(4) (d)RequirementHigh-risk

    The provider or prospective provider conducting real-world testing must be established in the Union or have appointed a legal representative established in the Union.

    "the provider or prospective provider conducting the testing in real world conditions is established in the Union or has appointed a legal representative who is established in the Union"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to non-EU legal-AI vendors conducting high-risk testing in the Union.

  8. Art. 60(4) (e)Data governanceHigh-risk

    Data collected and processed for real-world testing may be transferred to third countries only when appropriate and applicable Union-law safeguards are implemented.

    "data collected and processed for the purpose of the testing in real world conditions shall be transferred to third countries only provided that appropriate and applicable safeguards under Union law are implemented"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI testing involving cross-border processing of personal or confidential data.
    See
    Union data-protection law

  9. Art. 60(4) (f)RequirementHigh-risk

    Real-world testing must last no longer than necessary and no longer than six months, with one additional six-month extension only after prior notification to the market surveillance authority and an explanation of need.

    "the testing in real world conditions does not last longer than necessary to achieve its objectives and in any case not longer than six months"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers setting duration for high-risk real-world tests.
    See
    Market surveillance authority

  10. Art. 60(4) (g)Risk managementHigh-risk

    Persons belonging to vulnerable groups due to age or disability who are subjects of real-world testing must be appropriately protected.

    "the subjects of the testing in real world conditions who are persons belonging to vulnerable groups due to their age or disability, are appropriately protected"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI tests involving children, older persons, or persons with disabilities.

  11. Art. 60(4) (h)Cooperation with authoritiesHigh-risk

    When a provider or prospective provider tests with deployers or prospective deployers, they must inform them of relevant testing aspects, provide Article 13 instructions for use, and conclude an agreement specifying roles and responsibilities for compliance.

    "the latter have been informed of all aspects of the testing that are relevant to their decision to participate, and given the relevant instructions for use of the AI system referred to in Article 13"
    Who
    Provider, Deployer
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant when law firms, courts, or legal departments participate as deployers in high-risk tests.
    See
    Art. 13

  12. Art. 60(4) (i)Information to personsHigh-risk

    Real-world testing subjects must give informed consent under Article 61, except in the specified law-enforcement case where testing and outcomes must not negatively affect subjects and personal data must be deleted after the test.

    "the subjects of the testing in real world conditions have given informed consent in accordance with Article 61"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers running tests with clients, employees, court users, or the public.
    See
    Art. 61

  13. Art. 60(4) (j)Human oversightHigh-risk

    Real-world testing must be effectively overseen by the provider or prospective provider and by participating deployers or prospective deployers through suitably qualified persons with the necessary capacity, training and authority.

    "the testing in real world conditions is effectively overseen by the provider or prospective provider, as well as by deployers or prospective deployers through persons who are suitably qualified"
    Who
    Provider, Deployer
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to law firms, courts, or legal departments participating in supervised high-risk testing.

  14. Art. 60(4) (k)Human oversightHigh-risklegal practice

    The predictions, recommendations or decisions of the AI system used in real-world testing must be capable of being effectively reversed and disregarded.

    "the predictions, recommendations or decisions of the AI system can be effectively reversed and disregarded"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — High for legal or justice AI tests because AI outputs must not irreversibly determine legal outcomes.

  15. Art. 60(5)Right of personHigh-risk

    Any real-world testing subject, or legally designated representative, may withdraw at any time without detriment or justification by revoking informed consent and may request immediate and permanent deletion of personal data.

    "Any subjects of the testing in real world conditions, or their legally designated representative, as appropriate, may, without any resulting detriment and without having to provide any justification, withdraw from the testing at any time"
    Who
    Natural person
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to individuals participating in legal-AI or justice-AI real-world tests.
    See
    Art. 61

  16. Art. 60(6)Enforcement powerHigh-risk

    Member States must confer powers on market surveillance authorities to require information, conduct unannounced remote or on-site inspections, and check real-world testing and related high-risk AI systems; authorities must use those powers to ensure safe testing development.

    "Member States shall confer on their market surveillance authorities the powers of requiring providers and prospective providers to provide information, of carrying out unannounced remote or on-site inspections"
    Who
    Member State, Market surveillance authority
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Legal practice
    Institutional — Enforcement powers may affect legal-AI providers conducting high-risk real-world testing.
    See
    Art. 75

  17. Art. 60(7)Risk managementHigh-risk

    After a serious incident in real-world testing, the provider or prospective provider must adopt immediate mitigation measures or suspend testing until mitigation occurs, or otherwise terminate it.

    "The provider or prospective provider shall adopt immediate mitigation measures or, failing that, shall suspend the testing in real world conditions until such mitigation takes place, or otherwise terminate it"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers managing incidents during high-risk testing.
    See
    Art. 73

  18. Art. 60(7)MonitoringHigh-risk

    Upon termination of real-world testing after a serious incident, the provider or prospective provider must have a procedure for promptly recalling the AI system.

    "The provider or prospective provider shall establish a procedure for the prompt recall of the AI system upon such termination of the testing in real world conditions"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers terminating a high-risk test after an incident.
    See
    Art. 73

  19. Art. 60(7)Incident reportingHigh-risk

    Any serious incident identified during real-world testing must be reported to the national market surveillance authority in accordance with Article 73.

    "Any serious incident identified in the course of the testing in real world conditions shall be reported to the national market surveillance authority in accordance with Article 73"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers if high-risk testing causes or reveals serious incidents.
    See
    Art. 73

  20. Art. 60(8)Cooperation with authoritiesHigh-risk

    Providers or prospective providers must notify the national market surveillance authority in the testing Member State of suspension or termination of real-world testing and of final outcomes.

    "Providers or prospective providers shall notify the national market surveillance authority in the Member State where the testing in real world conditions is to be conducted of the suspension or termination of the testing in real world conditions and of the final outcomes"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers closing or suspending high-risk tests.
    See
    Market surveillance authority

  21. Art. 60(9)RequirementHigh-risk

    The provider or prospective provider is liable under applicable Union and national liability law for damage caused during real-world testing.

    "The provider or prospective provider shall be liable under applicable Union and national liability law for any damage caused in the course of their testing in real world conditions"
    Who
    Provider
    From
    (Art. 113 second subparagraph)Chapter III Sections 1-3 apply from 2027-12-02 for Annex III high-risk systems and 2028-08-02 for Annex I high-risk systems under Art. 113(c) as amended; this row applies when the relevant high-risk rules bite.
    Legal practice
    Reaches legal-AI vendors or public bodies — Relevant to legal-AI providers because liability remains for harms during high-risk tests.

Cite

Regulation (EU) 2024/1689, Article 60 (Testing of high-risk AI systems in real world conditions outside AI regulatory sandboxes), as amended by Regulation (EU) 2026/1744, consolidated text of 27 July 2026, https://eur-lex.europa.eu/eli/reg/2024/1689/2026-07-27/eng#art_60 — text © European Union; only the Official Journal is authentic. Coding: SafeLegalAI (published by Cognesio LLP), "EU AI Act, structured", safelegalai.com/regulation/eu-ai-act/article-60, accessed 2026-09-08, CC BY 4.0.