Under the draft EU AI Regulation, conformance with harmonised standards creates a presumption of conformity for high-risk AI applications and services.
Notes on verification
Confirmed by the statutory text (Article 40 AI Act), official EU Commission FAQ pages, and independent academic legal analyses, all converging on the same mechanism of presumption of conformity via harmonised standards.
Sources
- OII | Harmonising Artificial Intelligence (oii.ox.ac.uk)
- https://artificialintelligenceact.eu/article/40/ (artificialintelligenceact.eu)
- https://digital-strategy.ec.europa.eu/en/faqs/navigating-ai-act (digital-strategy.ec.europa.eu)
- https://digital-strategy.ec.europa.eu/en/faqs/understanding-standardisation-ai-act (digital-strategy.ec.europa.eu)
- https://www.cambridge.org/core/journals/european-journal-of-risk-regulation/article/european-ai-standards-technical-standardisation-and-implementation-challenges-under-the-eu-ai-act/E5157BA0391FFA9E1A3233E636005192 (cambridge.org)
- https://www.tandfonline.com/doi/full/10.1080/13600834.2025.2570966 (tandfonline.com)