Article 6Chapter III — High-Risk AI Systems
Classification Rules for High-Risk AI Systems
High-Risk
Summary
Defines when an AI system qualifies as high-risk: either as a safety component of products requiring EU conformity assessment (Annex I), or if explicitly listed in Annex III. Provides a self-assessment pathway for systems that pose no significant risk despite being listed in Annex III.
Keywords
high-riskclassificationAnnex IAnnex IIIsafety componentconformity assessment
Legal Text
Article 6 — Classification Rules for High-Risk AI Systems 1. Irrespective of whether an AI system is placed on the market or put into service independently from 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 Section A of 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 putting into service of that product pursuant to the Union harmonisation legislation listed in Section A of 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.