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White paperMichael Clark
The Machinery Regulation Is the AI Regulation
For AI-enabled machinery the Machinery Regulation, applying from 20 January 2027, is the operative AI regulation, and since Regulation (EU) 2026/1744 moved it to Section B of the AI Act's Annex I, the AI Act's requirements reach machinery through it by delegated acts applying by 2 August 2028. Self-evolving machine learning safety components fall in Annex I Part A and need a notified body whatever standards are applied. The first steps are to classify each product line against Part A and write to a notified body, then record the change envelope.
Key findings
- The Machinery Regulation applies from 20 January 2027, more than eighteen months before the AI Act's high-risk rules for Annex I products, with no grace period for new placements.
- Since Regulation (EU) 2026/1744 moved machinery to Section B of the AI Act's Annex I, only Article 6(1), Article 60a and Articles 102 to 112 of the AI Act apply to high-risk AI in machinery.
- Safety components with self-evolving machine learning behaviour, and machinery embedding them, need a notified body under Annex I Part A even where harmonised standards are applied in full.
In the paper
- The AI Act reaches machinery through the Machinery Regulation
- Safety software sold separately can be a product
- A notified body, whatever standards are applied
- What Annex III asks of AI
- Who becomes the manufacturer after a change
- Where to start
Michael Clark
Chief Executive Officer, Standard Intelligence
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