IN BRIEF

The AI Act does not regulate every product that contains software. For products, the central question is whether the AI system is itself a product covered by legislation listed in Annex I to Regulation (EU) 2024/1689, or is intended to be used as a safety component of such a product, and whether that product must undergo third party conformity assessment under the same legislation. If both conditions in Article 6(1) are met, the system is classified as high risk. How much of the AI Act then applies depends on whether the legislation sits in Section A or Section B of Annex I, a distinction changed for machinery by Regulation (EU) 2026/1744. The high risk rules for Annex I systems apply from 2 August 2028.

01 / PRODUCTS MACHINERY VEHICLES

What does the product route in the AI Act cover?

Article 6(1) creates a product route into high risk classification that is separate from the use case list in Annex III. It asks first about the product and the role of the AI system inside it. The AI system must be intended to be used as a safety component of a product, or must itself be a product, and the product must be covered by Union harmonisation legislation listed in Annex I. A safety component is defined in Article 3 by reference to a component whose failure or malfunction endangers the health and safety of persons or property. That definition turns on the function of the component and on the consequence of its failure, not on whether the supplier calls the component intelligent, smart or merely software. A second condition must also be met. The product, or the AI system itself, must be required to undergo a third party conformity assessment before it is placed on the market or put into service under the same Annex I legislation. Both conditions work together. An AI feature in a regulated product does not automatically meet them, and a product that can be self assessed under its own sector legislation does not meet the second condition on that ground alone. Readers should record the product legislation relied on, the safety component reasoning and the conformity assessment route for each product, and should confirm the reading with a competent authority or legal adviser before treating a product as inside or outside this route.

02 / PRODUCTS MACHINERY VEHICLES

Why does the Section A and Section B distinction matter?

Annex I is divided into Section A and Section B, and the division changes what follows classification. Section A lists Union harmonisation legislation based on the New Legislative Framework. Section B lists legislation with sector specific conformity assessment procedures, including civil aviation, motor vehicles, agricultural and forestry vehicles, two and three wheel vehicles and marine equipment. For systems related to Section B products, Article 2(2) as amended limits the AI Act provisions that apply directly, naming Article 6(1), Article 60a and Articles 102 to 112, with Articles 57 to 59 applying only so far as the high risk requirements have been integrated into the sector legislation. The practical effect is that the substantive AI requirements are expected to arrive through the sector legislation itself rather than through a direct application of the full high risk chapter. For Section A products, the high risk requirements in Chapter III apply and are assessed through the product conformity procedure, subject to the conditional limitation rule added as Article 2(13) for equivalent or higher protection in the sector legislation, which the Commission must specify by delegated act. The distinction therefore affects who assesses what, under which procedure and with which documents. It does not remove the classification question. A team that confuses the two sections can overstate the direct AI Act duties for a Section B product or understate the sector work needed to integrate them.

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Where does machinery sit after Regulation (EU) 2026/1744?

Machinery is the clearest warning against relying on an early summary of Annex I. Regulation (EU) 2026/1744 moved Regulation (EU) 2023/1230 on machinery from Section A to Section B of Annex I and updated the reference so that it points to the Machinery Regulation rather than to the former Machinery Directive. For machinery, the application of the AI Act to high risk systems classified under Article 6(1) is therefore limited in the way Article 2(2) describes for Section B products. At the same time, the amending regulation requires the Machinery Regulation to incorporate essential health and safety requirements for the relevant high risk AI systems, with a consistent level of protection, through delegated acts amending its Annex III. A reader who still works from a pre amendment list that places machinery in Section A will plan the wrong conformity route. The correct starting point is the consolidated Annex I as amended, read alongside the current Machinery Regulation. Product teams should also check the transitional provisions of the Machinery Regulation itself, because the machinery regime has its own application and transition timetable that is separate from the AI Act dates in this guide. Any claim about which machinery rules apply on a given date should be checked against the current texts of both instruments.

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How do the product guides in this cluster fit together?

This cluster moves from the general map to individual product families. The next guide compares Section A and Section B in detail and lists the families in each section as they appear in the consolidated Annex I. Separate guides then deal with machinery and workplace safety, vehicles and transport, toys and childcare products, medical devices and in vitro diagnostic devices, radio equipment and lifts, consumer products and the general product safety safety net, and the product manufacturer role under Article 25. Two cross cutting guides deal with substantial modification and with product conformity timelines. The order is deliberate. A reader who starts with a single product family without the Section A and Section B map can miss the reason why two similar products follow different assessment routes. A reader who starts only with the map without the product family detail can miss the sector conditions that decide the third party assessment condition in Article 6(1). The guides therefore cross refer to each other, and each one states its own limits. None of them decides whether a named commercial product is high risk. That decision needs the product documentation, the intended purpose as presented to users, and the applicable sector legislation, checked by a competent person.

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What should a product team record before the 2 August 2028 date?

The high risk rules for Annex I systems apply from 2 August 2028 under Article 113 as amended by Regulation (EU) 2026/1744. That date is an application date, not a reason to leave product records until 2028. A useful record for each product names the product, the AI functions it contains, the intended purpose in the instructions and promotional material, whether any function is presented or used as a safety component, the Annex I legislation that covers the product, whether third party conformity assessment is required under that legislation, and the evidence for each answer. It also records changes over time, because a later change to intended purpose or to a safety function can change the classification analysis. The record should separate facts from conclusions. A fact is that a sensor function stops a machine when a guard is opened. A conclusion is that the function is a safety component. The record should show who made the conclusion, on what date and on what evidence, so that a later reviewer can test it. Where a product family is covered by more than one Annex I instrument, the record should address each one rather than choosing the most familiar. Where the answer is uncertain, the record should say so and note the authority or adviser asked to confirm it.

Continue with how Annex I Section A and Section B differ.

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What does this overview not decide?

This overview does not decide whether any particular product, machine, vehicle, toy, medical device or item of radio equipment is high risk, and it does not tell a manufacturer what it must do for a specific product. It does not reproduce the full Annex I list, it does not settle the meaning of safety component for a borderline function, and it does not describe the conformity assessment procedure of any sector instrument in full. Sector legislation changes, Annex I is amended, and delegated acts under Regulation (EU) 2026/1744 may specify further detail for machinery and for Section A limitations. A reader who needs a decision for a product that is about to be placed on the market should confirm the current consolidated Annex I, the current sector text and the current guidance with a competent authority or legal adviser, and should not treat this general overview as a legal determination for that product.

FAQ / PRACTICAL QUESTIONS

Frequently asked questions

Does every product with AI inside it become high risk under the AI Act?

No. The product route in Article 6(1) needs two conditions together: the AI system is itself a product covered by Annex I legislation or is intended to be used as a safety component of such a product, and the product must undergo third party conformity assessment under that legislation. Many products with AI functions meet neither condition, and some meet only one. The classification must be worked through product by product, with the sector legislation checked, rather than assumed from the presence of AI.

What changed for machinery in Regulation (EU) 2026/1744?

Regulation (EU) 2026/1744 moved Regulation (EU) 2023/1230 on machinery from Section A to Section B of Annex I. For machinery related high risk systems, Article 2(2) then limits the AI Act provisions that apply directly, while the Machinery Regulation is to incorporate consistent essential health and safety requirements for the relevant systems. Readers should work from the consolidated Annex I as amended and check the current Machinery Regulation, rather than from a pre amendment list.

When do the Annex I high risk rules apply?

Under Article 113 as amended by Regulation (EU) 2026/1744, the Chapter III high risk rules apply from 2 August 2028 for AI systems classified as high risk under Article 6(1) and Annex I. That is distinct from the 2 December 2027 date for Annex III systems. Entry into force of the original Regulation was 1 August 2024, which is a different event from application of these rules. Transitional provisions in Article 111 and in the sector legislation itself may also be relevant and should be checked separately.

Does a CE mark under sector legislation show AI Act compliance?

Not by itself. A CE mark shows conformity with the legislation under which it was affixed, following the procedure that legislation requires. For a Section A product, the AI Act high risk requirements are assessed within the product conformity procedure, but the mark does not prove that every AI Act question was correctly decided, and for a Section B product the route is different again. The conformity file, the declaration and the sector rules must be read together, and a competent authority or legal adviser should confirm the position for a specific product.

RELATED / CLUSTER PATHWAYS

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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 ↗European Commission AI Act overview ↗