🚨 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.
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