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Regulation Tracker / EU AI Act / Chapter III · Section 5

Article 43
Conformity assessment

Chapter III — Classification rules for high-risk AI systems, Section 5 — Harmonised standards and standardisation deliverables. 6 distinct duties, powers or definitions are coded from this article, applying from 2026-08-02. 2 reach legal practice directly.

Amended by Regulation (EU) 2026/1744 (Digital Omnibus on AI), in force 2026-07-27 — about 428 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. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the provider shall opt for one of the following conformity assessment procedures based on:

  1. (a)the internal control referred to in Annex VI; or
  2. (b)the assessment of the quality management system and the assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.

2. For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment procedure based on internal control as referred to in Annex VI, which does not provide for the involvement of a notified body.

3. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider of the system shall follow the relevant conformity assessment procedure as required in accordance with the relevant Union harmonisation legislation. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Assessment of the quality management system set out in Article 17 shall also be undertaken, and points 3, 4.3, 4.4. and 4.5, the fifth paragraph of point 4.6 and point 5 of Annex VII shall apply.

4. High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure in the event of a substantial modification, regardless of whether the modified system is intended to be further distributed or continues to be used by the current deployer.

5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annexes VI and VII by updating them in light of technical progress.

6. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraphs 1 and 2 of this Article in order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the conformity assessment procedure referred to in Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into account the effectiveness of the conformity assessment procedure based on internal control referred to in Annex VI in preventing or minimising the risks to health and safety and protection of fundamental rights posed by such systems, as well as the availability of adequate capacities and resources among notified bodies.

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. 43(1)Conformity assessmentHigh-risk

    For Annex III point 1 high-risk AI systems using harmonised standards or common specifications, the provider must choose internal control or notified-body assessment of the quality management system and technical documentation.

    "the provider shall opt for one of the following conformity assessment procedures based on:"
    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 vendors of biometric high-risk AI systems, including any legal-sector use of such systems.
    See
    Annex III point 1 · Annex VI · Annex VII · Art. 40 · Art. 41

  2. Art. 43(2)Conformity assessmentHigh-risklegal practice

    For Annex III points 2 to 8 high-risk AI systems, providers must use the Annex VI internal-control conformity assessment procedure without notified-body involvement.

    "For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment procedure based on internal control as referred to in Annex VI"
    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 vendors of Annex III point 8 legal or judicial high-risk AI systems that must complete internal-control conformity assessment.
    See
    Annex III points 2 to 8 · Annex VI

  3. Art. 43(3)Conformity assessmentHigh-risk

    For high-risk AI systems under Annex I Section A harmonisation laws, the provider must follow the relevant sectoral conformity assessment and include the AI Act requirements, quality management assessment, and listed Annex VII points.

    "For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider of the system shall follow the relevant conformity assessment procedure"
    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 — Mostly indirect for legal practice unless a legal-AI product is embedded in a covered regulated product.
    See
    Annex I Section A · Art. 17 · Annex VII

  4. Art. 43(4)Conformity assessmentHigh-risklegal practice

    A high-risk AI system that has already undergone conformity assessment must undergo a new assessment after a substantial modification, whether redistributed or continued in use by the current deployer.

    "High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure in the event of a substantial modification"
    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-AI vendors and deployers when substantial modifications affect high-risk legal or justice systems.
    See
    Art. 3(23)

  5. Art. 43(5)Delegated or implementing actNot tier-specific

    The Commission may adopt delegated acts under Article 97 to update Annexes VI and VII in light of technical progress.

    "The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annexes VI and VII by updating them in light of technical progress"
    Who
    Commission
    From
    (Art. 113 second subparagraph)
    Legal practice
    Institutional — Institutional power that may change conformity procedures applicable to legal-AI vendors.
    See
    Art. 97 · Annex VI · Annex VII

  6. Art. 43(6)Delegated or implementing actNot tier-specific

    The Commission may amend Article 43(1) and (2) to require notified-body conformity assessment for Annex III points 2 to 8 systems, considering risk prevention and notified-body capacity.

    "The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraphs 1 and 2 of this Article in order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the conformity assessment procedure referred to in Annex VII"
    Who
    Commission
    From
    (Art. 113 second subparagraph)
    Legal practice
    Institutional — Institutional power that could later alter conformity routes for legal or justice high-risk AI systems.
    See
    Art. 97 · Annex III points 2 to 8 · Annex VII

Cite

Regulation (EU) 2024/1689, Article 43 (Conformity assessment), 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_43 — 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-43, accessed 2026-09-08, CC BY 4.0.