Annex I Section A and Section B (AI Act)

How it applies

• Section A: Products such as medical devices, in vitro diagnostics, toys and radio equipment. AI that is a safety component of such a product and needs third-party assessment is a high-risk AI system; the requirements apply from August 2, 2028 and are checked in the product's own conformity assessment.
• Section B: Sector legislation such as vehicles, civil aviation and marine equipment — and, since the Digital Omnibus on AI, machinery. Under Article 2(2) AI Act only a few of its provisions apply directly; the requirements reach the products through delegated or implementing acts under the sector law.
• Machinery: Recital 42 of Regulation (EU) 2026/1744 calls the move a sectoral approach for AI-enabled machinery. The route runs through the Machinery Regulation and its Article 8 delegated acts; see the machinery AI timeline.
• Technical documentation: State which legal route applies to each AI function and cite the AI Act “as amended by Regulation (EU) 2026/1744”. Documents written before July 2026 that describe machinery as Section A need revising.

Section A vs. Section B

The difference is the legal route, not the level of scrutiny. Section A products are checked against the AI Act requirements themselves; Section B products are checked against sector requirements that are to reflect them. For machinery this means the AI assessment begins with the Machinery Regulation in 2027 rather than with the AI Act in 2028.

Compared with the USA, Canada and China

The layering of a horizontal AI law onto existing product law is specific to the EU. In the USA, sector regulators such as the FDA, NHTSA and FAA handle AI within their existing product rules; Canada follows the same pattern with Health Canada and Transport Canada. China has no product-oriented AI law; its AI rules address online services and content.