Set by the law · AI Act Art. 6(1)

High-risk AI system

In plain English

An AI system that is, or is a safety component of, a product needing third-party checks under EU product laws, or an AI system listed in Annex III, unless it poses no significant risk of harm.

The official text

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 … is required to undergo a third-party conformity assessment

Regulation (EU) 2024/1689 (AI Act), Article 6(1)EUR-LexRead it on Fino →

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.

Regulation (EU) 2024/1689 (AI Act), Article 6(2)EUR-LexRead it on Fino →

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

Regulation (EU) 2024/1689 (AI Act), Article 6(3)EUR-LexRead it on Fino →

Related

The official text is quoted word for word from the English version of the source named under it; only the version published in the Official Journal of the EU is legally binding. The plain-English line is Fino’s own summary, not legal advice.