Machinery Regulation Article 8 delegated acts

How it applies

• What is added: The provisions named are the AI Act's high-risk requirements (Chapter III Section 2: risk management, data governance, technical documentation, record-keeping, transparency, human oversight, accuracy, robustness and cybersecurity), the quality management system (Article 17), automatically generated logs (Article 19), post-market monitoring (Article 72) and serious incident reporting (Article 73).
• What is not changed: The delegated acts refine the machinery assessment; they do not replace the Annex III requirements that apply from January 20, 2027. See the machinery AI timeline.
• Possible evidence: Depending on the final text: data governance, model robustness, training and validation evidence, performance monitoring, human oversight structures and fail-safe behavior for learning systems.
• Technical documentation: Build the technical file so these items can be added without restructuring — for example a dedicated section per AI function with its data, model version and validation records.

Compared with the USA, Canada and China

No comparable mechanism exists in the other three: there is no binding act that imports AI requirements into machinery law. US and Canadian machine builders follow consensus standards; Chinese builders follow GB standards, some of which are aligned with ISO and IEC work on AI and functional safety.