AI for business · Regulation
Machinery Regulation — including machines with self-evolving behaviour
Replaces the Machinery Directive. Safety components with fully or partially self-evolving behaviour using machine learning require third-party conformity assessment.
Coming soonEUProducts and liabilityRegulation (EU) 2023/1230
What it means for AI
Robots, cobots and machines with AI safety functions: the machinery rules apply; the AI Omnibus moved the machinery regulation to Annex I Section B of the AI Act.
What you must do
- Risk assessment for autonomous and learning behaviour.
- Notified body assessment for AI-based safety components.
- Digital instructions allowed, with a paper copy on request.
Examples
A factory buys a collaborative robot that learns movements
Check the CE declaration covers the learning safety functions; train operators.
Key dates
The regulation enters into force.
The regulation applies (replaces Directive 2006/42/EC).
Official sources
Related regulations
Industry guides
General information, not legal advice — consult a lawyer for borderline cases. Regulations reviewed on 29 Sep 2026.