Is your AI system high-risk under the AI Act?

The Regulation does not apply to some systems at all. Three exclusions matter to a company; the open-source exclusion of Article 2(12) is not one of them, since it falls away for a system placed on the market as high-risk.

Section A lists the New Legislative Framework acts: toys, recreational craft, lifts, equipment for explosive atmospheres, radio equipment, pressure equipment, cableways, personal protective equipment, gas appliances, medical devices and in vitro diagnostics. Section B lists civil aviation security, two- and three-wheel vehicles, agricultural vehicles, marine equipment, rail interoperability, motor vehicles, civil aviation, and, since 27 July 2026, the Machinery Regulation (EU) 2023/1230, which moved from Section A. Software sold on its own is under neither unless it is one of these products.

Article 6(2) makes every system listed in Annex III high-risk by its intended purpose, wherever it is deployed. Pick the point that describes what the system is intended to do; the wording is the Regulation's own.

Article 111(2) gives systems on the market before the date Chapter III applies a grace period: the Regulation reaches them only when their design changes significantly. Answer for the type and model, not the individual unit.

A provider develops the system, or has it developed, and places it on the market or puts it into service under its own name (Article 3(3)); a deployer uses it under its own authority (Article 3(4)). A product manufacturer that places the system on the market together with its product under its own name is the provider (Article 25(3)).