• This session delved deep into the nuances of artificial intelligence (AI) regulation and its impact on medical devices. The session speakers explored and compared the legislative frameworks, specifically focusing on the EU Artificial Intelligence Act (the AI Act) but also mentioning the various approaches taken in the US
• The AI Act, Regulation (EU) 2024/1689, lays down harmonised rules on artificial intelligence. Its aim is to regulate the ethical use of AI and provide AI developers with clear requirements and obligations regarding specific uses of AI. The Act, which was published on 12 July 2024 and will be fully implemented by August 2027, aims to ensure that AI systems are safe, respect fundamental rights, foster AI investment, improve governance and encourage a harmonised single EU market for AI

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