EU Regulation 2024/1689, the first comprehensive legal framework for artificial intelligence, establishing risk-based obligations for AI providers and deployers. It entered into force in August 2024, with requirements phased in over the following years: prohibitions on certain practices first, transparency obligations for general-purpose models from 2025, and conformity requirements for high-risk systems phasing in from 2026. Many medical AI applications fall into the high-risk category and are regulated in conjunction with the MDR and IVDR.
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