António Silva

🚨 The European AI Act is here – and it brings new challenges for AI-based medical devices! 🎯 Key highlights from the paper: 📆 The high-risk scope under article 6(1)(AIA) will apply starting August 2, 2027 🛡️ Strong emphasis on fundamental rights like privacy, data protection, non-discrimination, and human dignity🔍 Critical definitions: AI system, safety component, substantial modification and significant change🏛️ Urgent need for designation of AI-ready Notified Bodies🔁 Risks associated with overlapping requirements between MDR/IVDR and the AI Act 💡 The message is clear: a harmonised, pragmatic approach is needed to ensure that innovation in healthcare is not delayed, and that stakeholders are prepared for the regulatory convergence of AI and medical technology. 📄 The full paper is available here. Let us know if this sounds interesting to you. I’d be happy to share more or schedule a quick call to explore how we can support your goals. Follow us on linked.in for regular updates.