European UnionMachinery Regulation, Conformity Assessment of Machine-Learning Safety Components and Embedded Systems (Annex I, Part A, Points 5 and 6)
Regulation (EU) 2023/1230, Annex I, Part A, points 5 and 6, with Article 25(2)
An AI sector rules rule binding public and private bodies.
As of .
What it requires
- This duty takes effect on (Article 54).
- If you are a manufacturer of a safety component with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions, or of machinery that embeds such a system and has not placed it independently on the market, apply one of the conformity assessment procedures in Article 25(2): EU type-examination (module B) followed by conformity to type (module C), full quality assurance (module H), or unit verification (module G) (Annex I, Part A, points 5 and 6).
Who enforces it
Settledness
- As of
- Open questions
- Does a machine learning model that is trained before the machinery is placed on the market and does not change afterwards have 'fully or partially self-evolving behaviour using machine learning approaches' under Annex I, Part A, points 5 and 6?
What this law does
Article 25(2) requires the manufacturer, for a category of machinery or related product listed in Annex I, Part A, to apply one of three conformity assessment procedures: EU type-examination (module B) followed by conformity to type based on internal production control (module C), conformity based on full quality assurance (module H), or conformity based on unit verification (module G).
Annex I, Part A, point 5, lists safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions. Annex I, Part A, point 6, lists machinery that has embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been placed independently on the market, in respect only of those systems.
Recital 54 states that the conformity assessment of a safety component or a system with self-evolving behaviour ensuring safety functions should be carried out by a third party.
Regulation (EU) 2026/1744 requires the Commission to adopt delegated acts adding health and safety requirements for AI systems that are classified as high-risk under Article 6(1) of the AI Act because they are a safety component in a product covered by the Machinery Regulation or are themselves such a product, and those delegated acts apply by . Article 54 provides that the Regulation applies from .
When LexLint raises it
When your app profile says your app distributes a software product.