Source: CMS Law-Now

CMS Law-Now provides an in-depth analysis of prEN 18286, the first draft harmonised standard for the EU AI Act to reach the public consultation stage, released on October 30, 2025. This standard specifically addresses the Quality Management System (QMS) requirements mandated by Article 17 of the AI Act for providers of high-risk AI systems. It serves as a critical tool for translating legal obligations into concrete, auditable processes, covering essential areas such as strategy, design controls, data governance, and post-market monitoring.

The article highlights that complying with the normative clauses of prEN 18286 will grant providers a "presumption of conformity" with the AI Act's essential requirements, facilitating market access. The draft standard is designed to integrate with existing frameworks like ISO 9001 and ISO/IEC 42001, minimizing the burden of implementation for organizations already utilizing these systems. The piece emphasizes the importance of Annex ZA, which maps the standard's clauses to specific legal requirements, and advises in-house legal teams to begin mapping their internal controls to these new regulatory benchmarks immediately.