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6min chapter
212 - Guest: Antonina Burlachenko, AI Regulatory Consultant
Artificial Intelligence and You
Implications of European AI Act on Medical Device Regulation
Discussion on how the European AI Act classifies AI systems, particularly high-risk AI systems, impacting medical devices already governed by regulations like MDR and IVDR. Exploration of the intersection between existing regulations and the new AI Act, including the challenges faced by providers of high-risk AI systems and medical devices in meeting the requirements.
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