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Life With GDPR – Navigating The EU AI Act
Regulatory Ramblings: Episode 51 - The EU AI Act: Why it Matters for Asia and Beyond with Michael Borrelli (AI & Partners) and Anandaday Misshra (AMLEGALS)
Life With GDPR: AI Regulation in The EU
Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more
Already highly regulated with a risk-based approach at their core, AI-powered medical devices and in vitro diagnostic medical devices face new regulatory constraints stemming from the EU AI Act, a horizontal legal instrument...more
On 19 June 2025, the Medical Device Coordination Group (“MDCG”) published new guidance on the interplay between the MDR & IVDR and the AI Act (MDCG 2025-6). The document provides a first set of answers to the most frequently...more