The document contains a comprehensive set of amendments aimed at simplifying the EU AI Act’s implementation, improving proportionality for SMEs/SMCs, reinforcing AI Office powers, prohibiting harmful AI misuse (like sexual deepfakes), clarifying conformity assessments, enabling real‑world testing, and aligning AI rules with sector‑specific safety legislation.
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- Product Management Services (PMS) – Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe
- AI Omnibus enters into force
- EU CTR Q&A Version 7.3 is Out
- New WHO guide on Artificial intelligence-related health research
- GDP for APIs: APIC Publishes Updated “How to Do” Document
- Team-NB Position Paper :TRANSFER AGREEMENT FOR SURVEILLANCE OF LEGACY DEVICES
- MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
- New ISO Guidance for AI-Powered Medical Devices: ISO/TS 24971-2:2026 Published!