Section A lists Union harmonisation legislation based on the New Legislative Framework, and Section B lists legislation with sector specific conformity assessment procedures. The section matters because Article 2(2) limits the AI Act provisions that apply directly to high risk systems related to Section B products, while Section A products follow the high risk requirements through the product conformity procedure. Machinery sits in Section B after Regulation (EU) 2026/1744. The consolidated Annex I itself is the only reliable list, and it must be checked in its amended form.
How is Annex I organised?
Annex I to Regulation (EU) 2024/1689 is headed as a list of Union harmonisation legislation. It is then divided into Section A and Section B. Section A is described as legislation based on the New Legislative Framework. That framework provides a common set of principles and reference provisions for product legislation, including conformity assessment modules and the role of notified bodies. Section B contains legislation that keeps its own sector specific procedures, such as type approval for vehicles and the aviation safety system. The division is not a ranking of importance and it is not a statement that one section is stricter than the other in substance. It is a statement about the legal architecture that already governs the product. A product team that treats the division as a label for risk will misunderstand it. The division tells the team which conformity system will carry the AI requirements, which authority structure applies, and which documents must be produced. The starting task is therefore to find the product in Annex I, note its section, and then read the sector legislation for that product in full.
Which product families appear in Section A?
Section A in the consolidated text includes, among others, toys under Directive 2009/48/EC, recreational craft and personal watercraft, lifts and safety components for lifts, equipment for potentially explosive atmospheres, radio equipment, pressure equipment, cableway installations, personal protective equipment, appliances burning gaseous fuels, medical devices under Regulation (EU) 2017/745 and in vitro diagnostic medical devices under Regulation (EU) 2017/746. That list is given here as an orientation to the kinds of legislation in the section, not as a substitute for the Annex itself. The Annex contains numbered entries with full citations and Official Journal references, and entries can be amended. A product that appears similar to a listed family is not necessarily covered by the listed instrument. Coverage depends on the scope provisions of the sector instrument, its exclusions and its definitions. For example, a device used in a clinical setting may or may not be a medical device under Regulation (EU) 2017/745, and only the scope and classification rules of that Regulation can settle the point. The guide on medical devices in this cluster explains that boundary in outline. For every other family, the same discipline applies: identify the instrument, read its scope, and record the reasoning.
For the broader regulatory framework, see products, machinery and vehicles overview.
Which product families appear in Section B?
Section B in the consolidated text includes civil aviation under Regulation (EU) 2018/1139, motor vehicles under the type approval framework, agricultural and forestry vehicles, two and three wheel vehicles and quadricycles, marine equipment, and, after the amendment by Regulation (EU) 2026/1744, machinery under Regulation (EU) 2023/1230. Rail and other transport legislation also needs to be checked in the consolidated Annex rather than assumed from older summaries, because the Annex is the controlling list and secondary summaries do not always reflect amendments. The common feature of Section B families is that each already has a detailed sector approval or certification system with its own authorities, procedures and technical requirements. The AI Act does not replace those systems. For high risk systems related to Section B products, Article 2(2) limits direct application to Article 6(1), Article 60a and Articles 102 to 112, and Articles 57 to 59 apply only so far as the high risk requirements have been integrated into the sector legislation. The sector system must therefore be examined for how, and when, it integrates the AI requirements. A vehicle or aviation reader who looks only at the AI Act chapter on high risk requirements will miss the operative rules.
How does the section change the conformity work?
For a Section A product, Article 43(3) provides that the conformity assessment for the high risk AI system follows the conformity assessment procedure required by the relevant sector legislation. The AI requirements are therefore assessed inside a procedure the manufacturer may already know, with the notified body involvement that the sector legislation requires. Technical documentation, the EU declaration of conformity and CE marking follow the combined procedure, and the file must show how the AI requirements were addressed. For a Section B product, the work is different. The manufacturer must follow the sector procedure and must track whether and how the sector legislation has integrated the AI requirements, including any delegated acts or sector amendments required by Regulation (EU) 2026/1744 for machinery. In both cases, the product team needs a single file that can be inspected, but the legal basis for each element of the file differs. A team that prepares a standalone AI Act file for a Section B product without linking it to the sector file risks duplication and gaps. A team that prepares only a sector file for a Section A product without addressing the AI requirements risks the same outcome from the other direction.
What is the Article 2(13) limitation for Section A products?
Regulation (EU) 2026/1744 added Article 2(13), which allows the application of specific AI Act requirements or obligations in Articles 9 to 15 and 17 to 25 to be limited for high risk systems under Article 6(1), where and to the extent that the Section A harmonisation legislation lays down requirements providing an equivalent or higher level of protection of health, safety or fundamental rights, and where the limitation does not reduce the overall level of protection provided by the AI Act. The Commission must adopt delegated acts by 2 August 2027 specifying the systems concerned, the requirements that may be limited, the conditions and the scope of the limitation. That mechanism is conditional and prospective. It does not authorise a manufacturer to disregard an AI Act requirement on the basis of a general impression that sector law is equivalent. Until the delegated acts specify the position, a manufacturer should treat the AI requirements as applicable in full through the sector procedure and should record any equivalence argument as an open question for confirmation. After the delegated acts appear, the record should be updated to cite the specific act, the requirement limited and the condition relied on. No guide can pre empt that specification.
Continue with machinery and safety components.
What does this guide not settle?
This guide does not list every Annex I entry, does not decide whether a particular product is covered by a listed instrument, and does not describe any sector conformity procedure in full. It does not predict the content of the Article 2(13) delegated acts, and it does not state that a Section B sector has completed integration of the AI requirements. The consolidated Annex I, the sector legislation and any delegated acts must be checked in their current form. Where a product sits near a scope boundary, or where two Annex I instruments could apply, the position should be confirmed with a competent authority or legal adviser before the product is placed on the market. This guide is a map to the questions, not a determination of the answers for any named product.
Frequently asked questions
Is Section A stricter than Section B?
No such general ranking should be assumed. Section A and Section B describe different legislative architectures. Section A products follow New Legislative Framework procedures, while Section B products follow sector specific procedures. The substantive level of protection is meant to be consistent, and for Section B products the AI requirements are to be integrated into the sector legislation. The practical difference is the route and the documents, not a simple statement that one section is stricter.
Did machinery move sections?
Yes. Regulation (EU) 2026/1744 moved Regulation (EU) 2023/1230 on machinery from Section A to Section B of Annex I and updated the reference to the Machinery Regulation. Any list or summary prepared before that amendment that places machinery in Section A is out of date for this purpose and should not be relied on without checking the consolidated Annex I.
Can a manufacturer rely on sector law alone and ignore the AI Act for a Section B product?
No. Classification under Article 6(1) still applies, Article 2(2) still names the AI Act provisions that apply directly, and the sector legislation must be checked for integration of the high risk requirements. Sector law alone is not a complete answer unless the sector text, as amended, actually integrates those requirements and the integration is cited in the conformity file. Confirm the position with a competent authority or legal adviser for the specific product.
Where is the authoritative Annex I list?
In the consolidated text of Regulation (EU) 2024/1689 on EUR-Lex, as amended by Regulation (EU) 2026/1744. The consolidated text linked in the sources for this guide is the version to check. Secondary summaries, including this guide, can become out of date when Annex I is amended, so the consolidated Annex should be rechecked on the date a decision is made.
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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 ↗