Regulatory Watch

, Gabin

EUDAMED in 2026: Concrete Obligations for Medical Device Manufacturers

In 2026, EUDAMED becomes mandatory for medical device manufacturers. What are the concrete obligations regarding traceability, consistency, and data updates?

Read the article

, Gabin

The Illusion of Transparency? What the Code of Practice on AI Does (and Doesn't) Change

In July 2025, the EU published a Code of Practice for general-purpose AI (GPAI) like ChatGPT. While it promotes transparency and safety, it remains voluntary. What does this mean for healthcare?

Read the article

, Hugo

Understanding the Requirements of the AI Act: How the Code of Conduct Impacts Developers and AI Integrators

Since the adoption of Regulation (EU) 2024/1689, AI stakeholders operating in Europe must comply with a strengthened legal framework. Discover the implications of the voluntary Code of Conduct for general-purpose AI models.

Read the article

, Hugo

The AI Act Explained for SMEs: Key Points to Prepare Effectively

The European Regulation on Artificial Intelligence (AI Act), which came into force in 2024, is the world's first major attempt to regulate AI systems. Discover the specific opportunities and obligations for SMEs.

Read the article