Article 6(1): the product route to high risk

Article 43(3) was replaced by Regulation (EU) 2026/1744. The third subparagraph of the new text reads: where Union harmonisation legislation listed in Section A of Annex I provides the product manufacturer with an option to rely on a conformity assessment that does not involve a third party, provided that that manufacturer has applied harmonised standards to ensure compliance with all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter. The classification of a product as a high-risk AI system in accordance with Article 6(1) does not affect the choice of the conformity assessment procedure provided to the manufacturers of products covered by Union harmonisation legislation listed in Section A of Annex I. The manufacturers of such products are not required to choose a conformity assessment procedure involving third-party conformity assessment only because the product includes a high-risk AI system as a safety component, if this is not required by that harmonisation legislation. The first subparagraph of the same paragraph provides that the requirements set out in Chapter III, Section 2, apply to those high-risk AI systems and form part of that assessment.

Article 2(2) was replaced by Regulation (EU) 2026/1744 and reads: for AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Article 60a and Articles 102 to 112 shall apply. Articles 57, 58 and 59 shall apply only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation. The original text named only Article 6(1), Articles 102 to 109 and Article 112, and limited the effect of Article 57 in the same way.

The same Regulation amends Annex I: in Section A point 1 is deleted and in Section B point 21 is added, Regulation (EU) 2023/1230 on machinery. Point 1 of Section A was Directive 2006/42/EC on machinery. Machinery therefore moves from Section A to Section B. Regulation (EU) 2023/1230 is amended at the same time so that the Commission adopts delegated acts supplementing Annex III to that Regulation with health and safety requirements for AI systems classified as high risk pursuant to Article 6(1) of Regulation (EU) 2024/1689, reflecting the requirements of Chapter III, Section 2, and Articles 17, 19, 72 and 73. Those delegated acts shall apply by 2 August 2028.

Article 2(1), point (e), provides that this Regulation applies to product manufacturers placing on the market or putting into service an AI system together with their product and under their own name or trademark. Article 25(3) provides that in the case of high-risk AI systems that are safety components of products covered by the Union harmonisation legislation listed in Section A of Annex I, the product manufacturer shall be considered to be the provider of the high-risk AI system and shall be subject to the obligations under Article 16 under either of the following circumstances: (a) the high-risk AI system is placed on the market together with the product under the name or trademark of the product manufacturer; (b) the high-risk AI system is put into service under the name or trademark of the product manufacturer after the product has been placed on the market. Article 25(3) was not amended by Regulation (EU) 2026/1744.

The text of Article 113, third paragraph, point (c), as published in the Official Journal provides that Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.

Regulation (EU) 2026/1744 replaces point (c) of the third paragraph of Article 113 with: Chapter III, Sections 1, 2, and 3, with the exception of Article 6(5), shall apply from (i) 2 December 2027 as regards AI systems classified as high-risk pursuant to Article 6(2) and Annex III, and (ii) 2 August 2028 as regards AI systems classified as high-risk pursuant to Article 6(1) and Annex I. The same amendment adds a point (d) to that paragraph: Articles 102 to 110 shall apply from 27 July 2026.

Article 111(2) was replaced and reads: without prejudice to the application of Article 5 as referred to in Article 113, third paragraph, point (a), this Regulation shall apply to operators of high-risk AI systems, other than the systems referred to in paragraph 1 of that Article, that have been placed on the market or put into service before the date of application of Chapter III referred to in Article 113, only if, as from that date, those systems are subject to significant changes in their designs. In any case, the providers and deployers of high-risk AI systems intended to be used by public authorities shall take the necessary steps to comply with the requirements and obligations laid down in this Regulation by 2 August 2030.

The inserted Article 2(13) provides that for high-risk AI systems referred to in Article 6(1), the application of specific requirements or obligations laid down in Articles 9 to 15 and 17 to 25 may be limited, where and to the extent that Union harmonisation legislation listed in Section A of Annex I lays down requirements or obligations providing an equivalent or higher level of protection, and such limitation does not reduce the overall level of protection provided for by this Regulation. By 2 August 2027 the Commission shall adopt delegated acts specifying the systems concerned, the requirements that may be limited, the conditions and the scope.

For most organisations the first question is not whether their system is AI, but what function their AI component performs and which section of Annex I their product falls under. What often goes wrong is the idea that the conformity route chosen determines the classification: we apply harmonised standards, therefore internal control, therefore no third party, therefore no high risk. That reasoning does not hold. The replaced Article 43(3) attaches an additional condition under this Regulation to the opt-out and states in the same subparagraph that classification as a high-risk AI system does not affect the choice of procedure, and the draft guidelines of 19 May 2026 read Article 6(1) the same way. Where you can genuinely fall outside this route is through the inserted paragraphs 1a and 1c: a model that solely supports throughput or quality control and whose failure does not endanger health and safety, and a product that needed a third party only because of radio spectrum or electromagnetic interference. Two further things go wrong in practice. The first is the date: whoever put 2 December 2027 in the plan because that was the date in the news is planning on the Annex III route and not their own, and whoever notes only 2 August 2028 misses that Articles 102 to 110 have applied since 27 July 2026. The second is the section: machinery has been in Section B since 27 July 2026, no longer in Section A. For a machine builder that means a different regime, with the requirements landing through delegated acts in Annex III to Regulation (EU) 2023/1230 rather than directly through Chapter III of this Regulation. What stands: if you do not build the AI system yourself but put it in your product under your own brand, Article 2(1), point (e), and Article 25(3) make you the provider, with the obligations of Article 16, and not merely a customer of your software supplier.