Article 6: Classification Rules for High-Risk AI Systems

Official Statutory Text

Article 6 Classification rules for high-risk AI systems 1. Irrespective of whether an AI system is placed on the marketor 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 componentof a product, or the AI system is itself a product, covered by the Uni on 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-par ty conformity assessment, with a view to the placing on the marketor the putting into service of that product pursuant to the Uni on 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 fulf illed: (a) the AI system is intended to performa narrow procedural task; (b) the AI system is intended to improve the resultof 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 performa preparatory task to an assessment relevant for the purposes of the use cases listed in Annex III. Notwithstanding the first subparagraph, an AI system refer red 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 marketor put into service. Such provider shall be subject to the registration obligation setout in Article 49(2). Upon requestof national competent author ities, the provider shall provide the documentation of the assessment. 5. The Commission shall, after consulting the European Artificial Intelligence Board (the ‘Board’), 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 listof practical examples of use cases of AI systems that are high-risk and not high-risk. 6. 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. 7. 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 forby this Regulation. 8. 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 protect ion of health, safety and fundamental rights provided forby this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and take accountof market and technological developments.