First EU AI Act Harmonised Standard Enters Public Enquiry as Brussels Pushes Compliance Framework
prEN 18286 quality management standard becomes first harmonised AI framework to enter public enquiry on 30 October 2025.
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First Harmonised AI Standard Advances Through EU Process
On 30 October 2025, prEN 18286 (Artificial Intelligence – Quality Management System for EU AI Act Regulatory Purposes) became the first harmonised AI standard to enter public enquiry. Developed by CEN and CENELEC through their joint technical committee JTC 21, the standard is specifically designed to help providers of high-risk AI systems comply with the AI Act’s Article 17 requirements, offering a product-focused framework for AI lifecycle governance.
How Harmonised Standards Work Under the AI Act
The European Commission requested that CEN and CENELEC develop harmonised standards for high-risk AI systems across ten key areas: risk management, governance and quality of datasets, record keeping, transparency, human oversight, accuracy, robustness, cybersecurity, quality management, and conformity assessment.
Crucially, application of harmonised AI Act standards is voluntary. Providers may use any other compliance framework, but harmonised standards referenced in the Official Journal of the EU provide legal certainty and a presumption of compliance—a significant advantage for organisations seeking to demonstrate regulatory alignment.
International-First Approach Opens Pathway for Global Standards
European Standardisation organisations follow an “international first” approach, meaning international standards—such as those developed by ISO/IEC SC 42—can become European harmonised standards when aligned with EU requirements. This approach allows Europe to leverage global standardisation efforts while maintaining regulatory control.
Separate Development: Citizens’ Initiative on Sovereign AI Governance
On 6 October 2026, the European Commission registered a European Citizens’ Initiative entitled “Creation of a European Digital Space (.IA) for Sovereign AI Governance.” The initiative invites the Commission to negotiate with ISO and ICANN with a view to safeguarding a dedicated .IA top-level domain.
Source: European Commission – Shaping Europe’s Digital Future