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AI Act: applicable, but high-risk duties are deferred

News · Regulatory evolution

Regulation (EU) 2024/1689 on artificial intelligence has applied since 2 August 2026, and that general date was not postponed. What was postponed is the product core of the instrument: Regulation (EU) 2026/1744 of 8 July 2026, published in OJ L of 24 July 2026 and in force since 27 July 2026, rewrote the third paragraph of Article 113 and pushed the high-risk obligations out to 2 December 2027 for Annex III and 2 August 2028 for Annex I.

In short:

  • The general date of 2 August 2026 stands: the second paragraph of Article 113 was not amended.
  • Regulation (EU) 2026/1744 is not a proposal, it is law in force.
  • The 2 August 2027 deadline for Article 6(1) no longer exists: the old point (c) was replaced outright.
  • Annex I high-risk duties now run to 2 August 2028, Annex III duties to 2 December 2027.
  • Machinery leaves Section A of Annex I, and third-party assessment required only for spectrum or EMC reasons no longer satisfies Article 6(1)(b).

Regulation (EU) 2024/1689 entered into force on 1 August 2024. Its Article 113 has three paragraphs: entry into force, the general date of application, then the derogations. The amending regulation touches only the third, and says so expressly: "in Article 113, the third paragraph is amended as follows". The consolidated timeline therefore reads as below.

DateWhat becomes applicable
2 February 2025Chapters I and II, except Article 5(1) first subparagraph points (ba) and (bb) and Article 5(1a) and (1b)
2 August 2025Chapter III Section 4, Chapters V, VII and XII, Article 78, except Article 101
27 July 2026Articles 102 to 110
2 August 2026General date of application of the Regulation
2 December 2026New prohibited practices in Article 5; Article 111(4) transition on synthetic content
2 December 2027Chapter III Sections 1 to 3, except Article 6(5), for high-risk under Article 6(2) and Annex III
2 August 2028Chapter III Sections 1 to 3, except Article 6(5), for high-risk under Article 6(1) and Annex I

Three observations. Chapter III Section 4, Articles 28 to 39, has applied since 2 August 2025: the apparatus for designating notified bodies is already in place. Article 6(5), the Commission guidelines on the practical implementation of Article 6, is expressly carved out of the deferral. And Section 5, Articles 40 to 49, which carries harmonised standards, conformity assessment, CE marking and registration, is named in no derogation at all: a textual observation from which the Regulation draws no explicit consequence while Sections 1 to 3 remain inapplicable.

The recitals give the reason for the deferral: the delayed availability of standards, common specifications and guidance, together with the delayed establishment of national competent authorities.

Article 6(1) itself is unchanged: an AI system is high-risk where it is a safety component of a product covered by the Union harmonisation legislation listed in Annex I, or is itself such a product, and that product must undergo a third-party conformity assessment. Regulation (EU) 2026/1744 inserts three paragraphs that filter this test.

  • Article 6(1a): AI systems used solely for non-safety related aspects, namely user assistance, performance optimisation, service efficiency, automation, convenience or quality control, do not qualify as safety components.
  • Article 6(1b): notwithstanding the above, an AI system whose failure or malfunctioning would endanger health and safety does qualify as a safety component.
  • Article 6(1c): a product required to undergo third-party conformity assessment solely because of 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, is not considered to fulfil the condition in paragraph 1, point (b).

The third point is the one that matters most to radio equipment manufacturers: where the only reason a third party is involved is spectrum or EMC, the Article 6(1)(b) condition is not met and the AI system is not high-risk by that route. A large class of RED products drops out of automatic classification.

Annex I is amended: point 1 of Section A, Directive 2006/42/EC, is deleted, and a point 21 is added to Section B for Regulation (EU) 2023/1230. The move is not cosmetic. Article 2(2) as amended provides that, for high-risk AI systems under Article 6(1) related to Section B products, only Article 6(1), Article 60a and Articles 102 to 112 apply, with Articles 57, 58 and 59 biting only where the AI Act requirements have been integrated into the sectoral legislation. The recital invokes "the specific nature of machinery and the machinery sector".

Section ASection B
ProductsToys, recreational craft, lifts, ATEX, radio, pressure equipment, cableway installations, PPE, gas appliances, medical devices, IVDsMachinery, Regulation (EU) 2023/1230
Reach of the AI ActFullArticle 6(1), Article 60a, Articles 102 to 112
Route for AI requirementsChapter III Section 2Annex III to Regulation (EU) 2023/1230

The amending regulation therefore reworks the Machinery Regulation itself. Its Article 8 gains new paragraphs: the Commission is to adopt delegated acts adding to Annex III of Regulation (EU) 2023/1230 health and safety requirements for AI systems classified as high-risk under Article 6(1), reflecting those of Chapter III Section 2 and Articles 17, 19, 72 and 73. "Those delegated acts shall apply by 2 August 2028." A new Article 20(10) builds a bridge: until standards specific to the Machinery Regulation are referenced for high-risk AI, compliance with the harmonised standards or common specifications adopted under Articles 40 and 41 of the AI Act gives a presumption of conformity with the corresponding Annex III requirements.

How this fits the existing CE conformity assessment

Section titled “How this fits the existing CE conformity assessment”

For products that stayed in Section A, the integration mechanics are untouched. Article 43(3) is the pivot: the provider follows the conformity assessment procedure required by the sectoral act, and the Chapter III Section 2 requirements form part of that assessment. There is no parallel procedure. Where the sectoral act lets a manufacturer opt out of third-party assessment by applying all harmonised standards, that option is open only if the manufacturer has also applied the standards, or the common specifications of Article 41, covering the Section 2 requirements.

The rest follows the same single-dossier logic, and each provision points expressly at Section A: a single set of technical documentation (Article 11(2)), the product manufacturer treated as the provider of the AI system (Article 25(3)), only the sectoral act's derogations available (Article 46(7)), post-market monitoring integrable into existing systems (Article 72(4)), market surveillance by the sectoral authority (Article 74(3)). Two changes ease the documentary load further: new Article 2(13), allowing certain requirements in Articles 9 to 15 and 17 to 25 to be limited where Section A legislation already provides equivalent or higher protection, and the amended Article 11(1), which extends the existing simplified Annex IV route from SMEs to small mid-caps.

  1. Re-run the Article 6(1) test against the three filters: a radio product whose AI serves user convenience, and whose third-party involvement rests only on spectrum or EMC, falls out of high-risk by that route.
  2. Revisit any plan built around 2 August 2027: the Article 6(1) deadline those plans rested on is gone.
  3. Treat machinery separately, under Regulation (EU) 2023/1230, applicable from 20 January 2027.
  4. Keep the documentation moving: the 2 December 2026 deadline on prohibited practices and synthetic content is close.

Sources & references

  1. Regulation (EU) 2026/1744 of 8 July 2026 (Digital Omnibus on AI) , EUR-Lex eur-lex.europa.eu/eli/reg/2026/1744/oj
  2. Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence , EUR-Lex eur-lex.europa.eu/eli/reg/2024/1689/oj
  3. Regulation (EU) 2023/1230 of 14 June 2023 on machinery , EUR-Lex eur-lex.europa.eu/eli/reg/2023/1230/oj