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Regulation Tracker / EU AI Act / Chapter III · Section 3

Article 16
Obligations of providers of high-risk AI systems

Chapter III — Classification rules for high-risk AI systems, Section 3 — Obligations of providers of high-risk AI systems. 12 distinct duties, powers or definitions are coded from this article, applying from 2027-12-02. 12 reach legal practice directly.

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

Providers of high-risk AI systems shall:

  1. (a)ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;
  2. (b)indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;
  3. (c)have a quality management system in place which complies with Article 17;
  4. (d)keep the documentation referred to in Article 18;
  5. (e)when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;
  6. (f)ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;
  7. (g)draw up an EU declaration of conformity in accordance with Article 47;
  8. (h)affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;
  9. (i)comply with the registration obligations referred to in Article 49(1);
  10. (j)take the necessary corrective actions and provide information as required in Article 20;
  11. (k)upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;
  12. (l)ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882.

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. 16 (a)RequirementHigh-risklegal practice

    Providers must ensure their high-risk AI systems comply with the requirements in Chapter III Section 2.

    "ensure that their high-risk AI systems are compliant with the requirements set out in Section 2;"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Chapter III Section 2 · Annex III point 8

  2. Art. 16 (b)TransparencyHigh-risklegal practice

    Providers must indicate their name, trade name or mark, and contact address on the system, packaging or accompanying documentation as applicable.

    "indicate on the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, as applicable, their name, registered trade name or registered trade mark, the address at which they can be contacted;"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Annex III point 8

  3. Art. 16 (c)Quality managementHigh-risklegal practice

    Providers must have a quality management system that complies with Article 17.

    "have a quality management system in place which complies with Article 17;"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Art. 17 · Annex III point 8

  4. Art. 16 (d)DocumentationHigh-risklegal practice

    Providers must keep the documentation referred to in Article 18.

    "keep the documentation referred to in Article 18;"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Art. 18 · Annex III point 8

  5. Art. 16 (e)Record keepingHigh-risklegal practice

    Providers must keep automatically generated logs under their control as referred to in Article 19.

    "when under their control, keep the logs automatically generated by their high-risk AI systems as referred to in Article 19;"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Art. 19 · Annex III point 8

  6. Art. 16 (f)Conformity assessmentHigh-risklegal practice

    Providers must ensure the high-risk AI system undergoes the relevant Article 43 conformity assessment before market placement or putting into service.

    "ensure that the high-risk AI system undergoes the relevant conformity assessment procedure as referred to in Article 43, prior to its being placed on the market or put into service;"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Art. 43 · Annex III point 8

  7. Art. 16 (g)Conformity assessmentHigh-risklegal practice

    Providers must draw up an EU declaration of conformity in accordance with Article 47.

    "draw up an EU declaration of conformity in accordance with Article 47;"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Art. 47 · Annex III point 8

  8. Art. 16 (h)Conformity assessmentHigh-risklegal practice

    Providers must affix CE marking to the high-risk AI system, packaging or documentation to indicate conformity with this Regulation.

    "affix the CE marking to the high-risk AI system or, where that is not possible, on its packaging or its accompanying documentation, to indicate conformity with this Regulation, in accordance with Article 48;"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Art. 48 · Annex III point 8

  9. Art. 16 (i)RegistrationHigh-risklegal practice

    Providers must comply with the Article 49(1) registration obligations for high-risk AI systems.

    "comply with the registration obligations referred to in Article 49(1);"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Art. 49(1) · Annex III point 8

  10. Art. 16 (j)MonitoringHigh-risklegal practice

    Providers must take necessary corrective actions and provide required information under Article 20.

    "take the necessary corrective actions and provide information as required in Article 20;"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Art. 20 · Annex III point 8

  11. Art. 16 (k)Cooperation with authoritiesHigh-risklegal practice

    Providers must demonstrate conformity with Section 2 requirements upon a reasoned request from a national competent authority.

    "upon a reasoned request of a national competent authority, demonstrate the conformity of the high-risk AI system with the requirements set out in Section 2;"
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Chapter III Section 2 · Annex III point 8

  12. Art. 16 (l)RequirementHigh-risklegal practice

    Providers must ensure high-risk AI systems comply with accessibility requirements under Directives (EU) 2016/2102 and (EU) 2019/882.

    "ensure that the high-risk AI system complies with accessibility requirements in accordance with Directives (EU) 2016/2102 and (EU) 2019/882."
    Who
    Provider
    From
    (Regulation (EU) 2026/1744 (Digital Omnibus on AI), Art. 1(40), amending Art. 113(c)(i): Art. 6(2)/Annex III high-risk)As enacted in 2024: (Art. 113 second subparagraph); deferred by Regulation (EU) 2026/1744 (Digital Omnibus on AI).Art. 111(2): high-risk AI systems placed on the market or put into service before 2026-08-02 are covered only if they are subject to significant design changes from that date; providers and deployers of high-risk AI systems intended for public authorities must take necessary steps to comply by 2030-08-02. Art. 113(c) separately applies Article 6(1) and corresponding obligations from 2027-08-02. Date deferred by Regulation (EU) 2026/1744 (in force 27 July 2026); as enacted: 2026-08-02 (Art. 113 second subparagraph).
    Fine tier
    Art. 99(4)
    Legal practice
    Reaches legal practice directly — Direct for legal-AI vendors where the system is high-risk under Annex III point 8, including AI used by or for judicial authorities or similarly in ADR.
    See
    Directive (EU) 2016/2102 · Directive (EU) 2019/882 · Annex III point 8

Cite

Regulation (EU) 2024/1689, Article 16 (Obligations of providers of high-risk AI systems), 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_16 — 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-16, accessed 2026-09-08, CC BY 4.0.