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From · Plenary report · 19 Mar 2026 A-10-2026-0073 on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2024/1689 and (EU) 2018/1139 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)
To · Adopted text · 26 Mar 2026 TA-10-2026-0098 Simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI)
✦ In short · AI narration of the differences below, generated 4 Sept 2026

The main substantive change adds a new condition for high-risk AI systems requiring third-party conformity assessment. #3 Other changes are formal or wording: correcting references, punctuation, and formatting. #1#2#4#5

1 change of substance, plus 8 formaland1 wording-only. Each change below carries a one-line ✦ note from the same model. Written from the two texts only — read the highlighted passages before relying on it.

The changes to the text itself, in document order. Cover page, citations (“having regard to …”), standard resolution paragraphs and punctuation-only edits are left out — they are in “Show every difference”.

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Change #3 Substance

Adds a new condition (b) to Article 6(1) requiring a third-party conformity assessment for high-risk AI systems.

Article 1 – paragraph 1 – point 5 b (new), Article 6 – paragraph 1: (5b) Article 6(1) is amended as follows: / "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 and whose functioning is necessary to ensure that the product or AI system complies with applicable Union safety requirements, 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."