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ARTICLE · 03 SEPTEMBER 2024

The European AI Office And Other Resources Relevant To High Risk AI Systems

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In our recent blog post, we reviewed the overall impact of the new EU AI Act on the life sciences industry.

European UnionTechnology
Jackie Mulryne
Jackie Mulryne
Eleri Abreo
Eleri Abreo
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In our recent blog post, we reviewed the overall impact of the new EU AI Act on the life sciences industry. The AI Act (Regulation (EU) 2024/1689), which entered into force on 1 August 2024, is the world's first comprehensive law regulating artificial intelligence (AI). While some provisions are already applicable, the provisions relating to high risk AI systems, which are those most likely to impact the life sciences industry, will apply from 2 August 2027.

The AI Act is horizontal legislation that applies across sectors. However, it is particularly important that developers and manufacturers of AI medical devices (AIMD) understand its implications given that AI systems used in these products are categorised as high-risk, and the AI Act imposes requirements and obligations in addition to those in the EU Medical Devices Regulations.

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