Article 6: Classification Rules for High-Risk Systems

Route A — Article 6(1) + Annex I: Where an AI system is a safety component of a product (or is the product) covered by Annex I Union harmonisation legislation and that product must undergo third-party conformity assessment before being placed on the market or put into service, the AI system is high-risk when both limbs (a) and (b) of paragraph 1 are met.

Route B — Article 6(2) + Annex III: AI systems referred to in Annex III are high-risk in addition to paragraph 1 systems—map your intended purpose to the Annex III categories in the Annex III guide.

Route C — Article 6(3) carve-out: An Annex III system is not high-risk if it does not pose a significant risk to health, safety, or fundamental rights and does not materially influence decision outcomes, only when one of the second-subparagraph conditions (a)–(d) applies—but profiling always keeps the system high-risk (third subparagraph). Providers self-assessing out of high-risk must document the assessment and comply with Article 49(2) registration (Article 6(4)).

Delegated adjustments: Articles 6(6)–(8) and Article 7 allow the Commission to refine lists and conditions via delegated acts—track EUR-Lex for updates.

• Article 1 — High-risk classification is part of the harmonised rule areas in Article 1(2)(c).
• Article 2 — Scope determines whether Article 6 tests apply to your actors and deployments.
• Article 3 — Definitions such as provider, deployer, intended purpose, and safety component anchor classification memos.
• Article 4 — AI literacy supports teams interpreting Article 6 and Annex III.
• Article 5 — Prohibited practices are a separate gate: if caught by Article 5, Article 6 classification is not a workaround.
• Article 7 — Commission delegated acts to amend Annex III use cases where risk is equivalent or greater.
• Annex III — Operational list for Article 6(2).
• Annex I — Product law hooks for Article 6(1).
• Article 49 — Registration when relying on Article 6(3) as non-high-risk (Article 6(4)).
• Articles 8–15 — Chapter III requirements once a system is high-risk.
• Article 97 — Empowerment for delegated acts referenced in Article 6(6)–(7).
• Article 113 — Application dates (including Article 6(1) timing referenced in the Act’s staged calendar—verify on EUR-Lex for your pathway).

Caution: Article 6(3) provides that an Annex III AI system is not high-risk if it does not pose a significant risk and does not materially influence decision outcomes, and one of the listed narrow purposes applies (a)–(d) in the authentic text.

These carve-outs do not apply where the system performs profiling of natural persons (Article 6(3), third subparagraph). Special-category personal data and profiling under Union law can also block reliance on the carve-out—see the complete text in the official wording section below. Always document the legal position before market release.

High-risk classification unlocks Chapter III (Articles 8–15), provider and deployer duties (Articles 16–27), conformity assessment, CE marking, EU database registration under Article 49, and post-market monitoring (e.g. Article 72), among others. Use the assessment tool to build a task list for your chain.

The following reproduces Article 6 in full from the English consolidated text of Regulation (EU) 2024/1689.

1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled:

(a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I;

(b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I.

2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be considered to be high-risk.

3. By derogation from paragraph 2, an AI system referred to in Annex III shall not be considered to be high-risk where it does not pose a significant risk of harm to the health, safety or fundamental rights of natural persons, including by not materially influencing the outcome of decision making.

The first subparagraph shall apply where any of the following conditions is fulfilled:

(a) the AI system is intended to perform a narrow procedural task;

(b) the AI system is intended to improve the result of a previously completed human activity;

(c) the AI system is intended to detect decision-making patterns or deviations from prior decision-making patterns and is not meant to replace or influence the previously completed human assessment, without proper human review; or

(d) the AI system is intended to perform a preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III.

Notwithstanding the first subparagraph, an AI system referred to in Annex III shall always be considered to be high-risk where the AI system performs profiling of natural persons.

4. A provider who considers that an AI system referred to in Annex III is not high-risk shall document its assessment before that system is placed on the market or put into service. Such provider shall be subject to the registration obligation set out in Article 49(2). Upon request of national competent authorities, the provider shall provide the documentation of the assessment.\n\n5. The Commission shall, after consulting the European Artificial Intelligence Board (the \u2018Board\u2019), and no later than 2 February 2026, provide guidelines specifying the practical implementation of this Article in line with Article 96 together with a comprehensive list of practical examples of use cases of AI systems that are high-risk and not high-risk.\n\n6. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by adding new conditions to those laid down therein, or by modifying them, where there is concrete and reliable evidence of the existence of AI systems that fall under the scope of Annex III, but do not pose a significant risk of harm to the health, safety or fundamental rights of natural persons.\n\n7. The Commission shall adopt delegated acts in accordance with Article 97 in order to amend paragraph 3, second subparagraph, of this Article by deleting any of the conditions laid down therein, where there is concrete and reliable evidence that this is necessary to maintain the level of protection of health, safety and fundamental rights provided for by this Regulation.\n\n8. Any amendment to the conditions laid down in paragraph 3, second subparagraph, adopted in accordance with paragraphs 6 and 7 of this Article shall not decrease the overall level of protection of health, safety and fundamental rights provided for by this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and take account of market and technological developments.

The recitals in the same consolidated AI Act on EUR-Lex contextualise risk classification, Annex III policy choices, and proportionality behind Article 6(3). Use the official preamble on EUR-Lex—do not rely on unofficial recital lists without checking sequence and wording against the authentic text.