Your Variation Identification Agent for Post Approval Change Management Watch Via in Action
The European Union has proposed amendments to the AI Act (EU 2024/1689) and related aviation regulations to simplify implementation of harmonized Artificial Intelligence (AI) rules across the EU.
The proposal aims to reduce regulatory complexity and compliance burdens, particularly for high-risk AI systems, while maintaining strong safeguards for safety, transparency, and fundamental rights.
Key updates include clearer definitions for AI system classifications, simplified conformity assessment procedures, and enhanced support for SMEs and small mid-cap companies (SMCs).
The regulation also introduces stricter prohibitions on harmful AI uses, including non-consensual intimate content and AI-generated child exploitation material.
Additional measures strengthen the role of the EU AI Office and national authorities, improve rules for bias detection and data governance, and establish AI regulatory sandboxes and real-world testing frameworks to encourage innovation.
The proposal reflects the EU’s effort to balance AI innovation, regulatory efficiency, and consumer protection through a risk-based governance approach.
Region: EU
Source: https://data.consilium.europa.eu/doc/document/ST-9247-2026-INIT/en/pdf
Reach out to us and let’s unravel your Regulatory puzzle together. Unlock regulatory solutions with our global subject matter experts and tap into a wealth of regulatory intelligence.
Speak to an Expert