What obligations does the provider of an AI system have under Article 6(1) of the AI Act?

Question

Article 6(1) of the AI Act covers the product route to high risk. An AI system counts as high risk where it is intended to be used as a safety component of a product covered by the Union harmonisation legislation listed in Annex I, or is itself such a product, and that product is required to undergo a third-party conformity assessment. This route does not run through Annex III but through the product legislation that already applies to the product. For Section A products the requirements of Chapter III, Section 2, form part of the sectoral assessment under Article 43(3); for Section B products Article 2(2) limits the operation of this Regulation to a short list of provisions. The duty sits with the provider of an AI system. This obligation starts to apply on 2 August 2028.

Accepted Answer

Your question is about Article 6(1): the product route to high risk. That obligation applies from 2 August 2028. Whether your system actually falls under it depends on conditions you assess yourself. Article 6(1) of the AI Act covers the product route to high risk. An AI system counts as high risk where it is intended to be used as a safety component of a product covered by the Union harmonisation legislation listed in Annex I, or is itself such a product, and that product is required to undergo a third-party conformity assessment. This route does not run through Annex III but through the product legislation that already applies to the product. For Section A products the requirements of Chapter III, Section 2, form part of the sectoral assessment under Article 43(3); for Section B products Article 2(2) limits the operation of this Regulation to a short list of provisions. The duty sits with the provider of an AI system. This obligation starts to apply on 2 August 2028. Still to determine: 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. Whether the system is placed on the market independently of that product is irrelevant. That product, or the AI system as a product itself, is required under that same harmonisation legislation to undergo a third-party conformity assessment with a view to its placing on the market or putting into service. Both conditions must be fulfilled together. Article 6(1a), inserted by Regulation (EU) 2026/1744, provides that AI systems solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control do not qualify as safety components. Paragraph 1b takes that exclusion back as soon as failure or malfunctioning would endanger health and safety. Article 6(1c), as inserted, provides that a product required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, is not considered to fulfil the condition in paragraph 1, point (b). First step: Establish the product route per product. Relevant provisions: Article 6(1): the product route to high risk. First actions: Establish the product route per product. Determine per product which Annex I legal act it falls under and whether that is Section A or Section B, which conformity assessment procedure applies there, which AI functions are safety components and who is thereby the provider. To record: Product route record.

What obligations does the provider of an AI system have under Article 6(1) of the AI Act?

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