EU AI Act and product law: conformity, safety components and sectoral rules

What is Union harmonisation legislation in this context?

Union harmonisation legislation means the product laws listed in Annex I to the AI Act, which set safety and conformity requirements for products placed on the Union market. The list includes, as examples, legislation on machinery, medical devices, toys, lifts, radio equipment, pressure equipment and vehicles, divided between Section A and Section B. The list in the consolidated Annex I should always be checked, because Regulation (EU) 2026/1744 amended the Annex, including the placement of machinery. A product team should identify the exact listed instrument that covers its product, the conformity procedure that instrument requires, and whether a notified body is involved, before drawing any AI Act conclusion.

How does Article 6(1) use Annex I?

Article 6(1) provides that an AI system is high-risk where both of two conditions are fulfilled: the system is intended to be used as a safety component of a product, or is itself a product, covered by the Union harmonisation legislation listed in Annex I; and the product is required to undergo a third-party conformity assessment under that legislation. Both conditions must be met. Coverage by a listed law alone is not enough, and a safety function alone is not enough without the third-party assessment condition. The Omnibus amendments added Article 6(1a) to (1c), which address systems used solely for non-safety aspects and assessments required solely for non-safety risks. Those paragraphs must be read with Article 6(1) in the consolidated text.

For the broader regulatory framework, see EU AI Act fundamentals.

What is the difference between Annex I Section A and Section B?

Section A lists legislation based on the New Legislative Framework, where the AI Act high-risk requirements are assessed within the product conformity procedure, under Article 43(3). Section B lists legislation with sector-specific conformity procedures, such as vehicles, aviation, rail and marine equipment, together with machinery following the Omnibus amendments. For Section B products, Article 2(2) provides that only specified AI Act provisions apply directly, including Article 6(1) and the final provisions, while the sectoral legislation carries the substantive requirements. The practical consequence is that the conformity route, the body that assesses it, and the documents produced can differ sharply between the two sections, even for similar AI functions.

How should conformity work be coordinated?

A manufacturer should run one coordinated conformity plan that maps each requirement to its source: the AI Act requirement, the sectoral product requirement, or both. Technical documentation, risk management, testing and post-market monitoring may overlap, but the evidence must satisfy each regime's own standard. The AI Act technical documentation in Annex IV, the product technical file, and any notified body involvement should be aligned so that a change in one file is reflected in the other. Where a product contains both an AI safety component and non-AI safety functions, the plan should show which assessment covers which function, and who is responsible for the interface between them.

What about products that are not in Annex I?

A product outside Annex I is not classified as high-risk through Article 6(1), but it can still be high-risk through Annex III if its intended use matches a listed use case, and it can still engage Articles 5 and 50. Consumer products, workplace tools and software products outside the Annex I list therefore still need the full classification analysis. Product safety law outside Annex I, general product safety rules, and sectoral rules for the specific product can also apply. The absence of an Annex I listing should be recorded as a finding about one route only, not as a finding that the system is outside the Act.

Continue with Article 6 classification routes.

What remains to be confirmed for a real product?

This guide explains the structure of the interplay. It does not determine whether a particular product is covered by Annex I, whether its AI function is a safety component, whether third-party assessment is required, or which conformity route applies. Those answers need the product's intended purpose, its safety functions, its failure effects, the exact listed instrument, and the conformity procedure that instrument prescribes. Product and AI Act assessments should be confirmed together with a competent authority or legal adviser and, where a notified body is involved, with that body, before the product is placed on the market. A joint confirmation, recorded with the product file and the AI file side by side, prevents the two regimes from drifting apart after release.

Frequently asked questions

Continue through this AI Act cluster

• EU AI Act fundamentals
• Article 6 classification routes
• Annex I Section A
• Annex I Section B
• AI Act and GDPR
• conformity assessment and CE marking