Annex I Section A lists Union harmonisation legislation based on the New Legislative Framework, including legislation on machinery in its pre-Omnibus placement, toys, lifts, equipment for potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft, cableway installations, gas appliances, and medical and in vitro diagnostic devices, as listed in the consolidated Annex I. For a system that meets Article 6(1) through a Section A product, the high-risk AI requirements are assessed as part of the conformity assessment procedure required by that product legislation, under Article 43(3). The current consolidated list must be checked, because Regulation (EU) 2026/1744 amended Annex I, including the placement of machinery.
What kind of legislation is in Section A?
Section A contains product legislation built on the New Legislative Framework, which uses a common pattern of essential requirements, harmonised standards, conformity assessment modules, CE marking and market surveillance. The legislation in the section covers products where safety is assessed through that common pattern, and where a notified body may be involved depending on the module. The AI Act builds on that pattern rather than creating a parallel product regime for Section A products. A manufacturer should therefore start from the product legislation that covers its product, identify the conformity module that applies, and then map the AI Act high-risk requirements into that module, rather than treating the AI Act as a separate product approval.
How is conformity assessed for Section A products?
Article 43(3) provides that, for high-risk AI systems that are safety components of products, or are themselves products, covered by the legislation in Annex I Section A, the provider must follow the conformity assessment procedure required by that legislation. In practice, the notified body or the internal control procedure that assesses the product also assesses the AI requirements, using the relevant harmonised standards and common specifications. The AI Act technical documentation, risk management and testing evidence must be available in the form the product procedure requires. The manufacturer should confirm with the notified body, where one is involved, how AI evidence will be presented, what standards will be applied, and what the timetable for assessment will be.
For the broader regulatory framework, see high-risk AI systems.
Which products illustrate Section A?
Illustrations from the consolidated list include medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746, toys under Directive 2009/48/EC, radio equipment under Directive 2014/53/EU, lifts under Directive 2014/33/EU, pressure equipment under Directive 2014/68/EU, personal protective equipment under Regulation (EU) 2016/425, and appliances burning gaseous fuels under Regulation (EU) 2016/426. Each illustration is only an illustration: the manufacturer must check the current Annex I entry, the product's scope under that instrument, and whether third-party assessment is required for that product. A product that is covered by a listed instrument but does not require third-party assessment does not meet the second Article 6(1) condition.
What must be coordinated in documentation?
The AI Act requires technical documentation under Article 11 and Annex IV, a risk management system under Article 9, data governance under Article 10, logging under Article 12, instructions for use under Article 13, human oversight design under Article 14, and accuracy, robustness and cybersecurity under Article 15. The product legislation requires its own technical file, risk assessment and instructions. The two sets of documents overlap but are not identical, and a manufacturer should maintain a mapping that shows where each AI requirement is evidenced in the product file, and where product evidence also serves an AI requirement. Version control must cover both sets together, so that a change to the AI component triggers review of the product file, and a change to the product triggers review of the AI classification.
What dates apply to Section A high-risk systems?
High-risk rules for Annex I product-embedded systems under Article 6(1) apply from 2 August 2028, under Article 113 as amended by Regulation (EU) 2026/1744. That date was 2 August 2027 before the Omnibus amendments. The later date does not postpone other duties: prohibitions, AI literacy, general-purpose model duties and transparency duties have their own earlier application dates, and product legislation duties apply on their own timetable. A manufacturer should therefore plan the AI conformity work to be ready well before August 2028, while meeting the earlier duties that already apply, and should record the provision alongside each date rather than treating August 2028 as a single deadline for everything.
Continue with Article 6 classification routes.
What does this guide not determine?
This guide explains the Section A structure and the conformity route in outline. It does not determine whether a particular product is covered by a Section A instrument, whether its AI function is a safety component, whether third-party assessment is required, or which conformity module applies. Those questions need the product's intended purpose, its safety functions, the listed instrument's scope, and the conformity procedure it prescribes, confirmed with the notified body where applicable and with a competent authority or legal adviser. The consolidated Annex I list should be checked at the time of assessment, because the list has been amended and may be amended again.
Frequently asked questions
Is a medical device with AI always high-risk under the AI Act?
Not automatically. Article 6(1) requires both the safety component or product condition and the third-party conformity assessment condition, tested against the consolidated Annex I and the medical device legislation. Both conditions must be checked for the specific device and AI function.
Does Section A require a separate AI conformity assessment?
No, as a general pattern. Article 43(3) provides that the AI requirements are assessed within the conformity procedure required by the Section A product legislation. The exact procedure depends on the module that applies to the product.
What if a product is covered by both Section A and Section B legislation?
The product team must identify each applicable instrument, the section in which it sits, and the conformity route for each. The record should show how the AI requirements are assessed for each instrument, rather than assuming one route covers the whole product.
Continue through this AI Act cluster
This article is an informational overview, not a legal determination. Check the current legal text and official implementation guidance for your system and role.
Consolidated Regulation (EU) 2024/1689 ↗AI Act Service Desk timeline ↗European Commission regulatory framework for AI ↗