in force 2026-07-27 MODIFIED+799 −0§
Amended by Digital Omnibus on AI 32026R1744
applies from: unchanged
The revised text inserts three new paragraphs, 1a, 1b and 1c, following paragraph 1, which were not present in the earlier version.
Paragraph 1a states that AI systems used solely for non-safety related aspects such as user assistance, performance optimisation, service efficiency, automation, convenience or quality control do not qualify as safety components, paragraph 1b states that AI systems whose failure or malfunctioning would endanger health and safety do qualify as safety components, and paragraph 1c states that a product required to undergo third-party conformity assessment solely for risks other than health and safety, such as radio spectrum or electromagnetic interference risks not affecting health and safety, is not considered to fulfil the condition in paragraph 1, point (b).
The rest of Article 6, including paragraphs 2 through 8, remains identical between the two versions.
Cited: Art. 6, v2 · Art. 6, v1
text before / after
32024R1689 → 02024R1689-20260727
Article 6 Classification rules for high-risk AI systems 1. Irrespective of whether an AI system is placed on the market or put into service independently of the products referred to in points (a) and (b), that AI system shall be considered to be high-risk where both of the following conditions are fulfilled: (a) the AI system is intended to be used as a safety component of a product, or the AI system is itself a product, covered by the Union harmonisation legislation listed in Annex I; (b) the product whose safety component pursuant to point (a) is the AI system, or the AI system itself as a product, is required to undergo a third-party conformity assessment, with a view to the placing on the market or the putting into service of that product pursuant to the Union harmonisation legislation listed in Annex I. 1a. For the purposes of this Regulation, including paragraph 1 of this Article, AI systems that are solely used for non-safety related aspects of user assistance, performance optimisation, service efficiency, automation or convenience or quality control shall not qualify as safety components. 1b. Notwithstanding paragraph 1a, AI systems the failure or malfunctioning of which would endanger health and safety shall qualify as safety components. 1c. A product that is required to undergo a third-party conformity assessment solely due to risks other than risks to health and safety, in particular risks relating to the distribution of radio spectrum or electromagnetic interference that do not affect health and safety, shall not be considered as fulfilling the condition in paragraph 1, point (b). 2. In addition to the high-risk AI systems referred to in paragraph 1, AI systems referred to in Annex III shall be considered to be high-risk. 3. By derogation from paragraph 2, an AI system referred to in Annex III shall … 432 unchanged words … shall not decrease the overall level of protection of health, safety and fundamental rights provided for by this Regulation and shall ensure consistency with the delegated acts adopted pursuant to Article 7(1), and take account of market and technological developments.