in force 2026-07-27 MODIFIED+490 −0§
Amended by Digital Omnibus on AI 32026R1744
applies from: unchanged
The definition of safety component in point (14) now adds a clarifying sentence stating that a component fulfils a safety function where its intended purpose is to prevent or mitigate risks to health and safety of persons or property.
Two new definitions have been inserted after point (14): point (14a) defines micro, small and medium-sized enterprise or SME by reference to Article 2 of the Annex to Recommendation 2003/361/EC, and point (14b) defines small mid-cap enterprise or SMC by reference to point (2) of the Annex to Recommendation (EU) 2025/1099.
Neither of these two new definitions nor the added clause in point (14) appear in the earlier text of Article 3.
Cited: Art. 3, v2 · Art. 3, v1
text before / after
32024R1689 → 02024R1689-20260727
Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) AI system means a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit … 449 unchanged words … safety component means a component of a product or of an AI system which fulfils a safety function for that product or AI system, or the failure or malfunctioning of which endangers the health and safety of persons or property; for the purposes of this definition, a component fulfils a safety function where its intended purpose is to prevent or mitigate risks to health and safety of persons or property; (14a) micro, small and medium-sized enterprise or SME means a micro, small or medium-sized enterprise as defined in Article 2 of the Annex to Recommendation 2003/361/EC; (14b) small mid-cap enterprise or SMC means a small mid-cap enterprise as defined in point (2) of the Annex to Recommendation (EU) 2025/1099; (15) instructions for use means the information provided by the provider to inform the deployer of, in particular, an AI system’s intended purpose and proper use; (16) recall of an AI system means any measure aiming to achieve the return to … 1,933 unchanged words … provider means a provider of an AI system, including a general-purpose AI system, which integrates an AI model, regardless of whether the AI model is provided by themselves and vertically integrated or provided by another entity based on contractual relations.