The many ambiguities of the European Union’s Artificial Intelligence Act
£45.00
Navigate the regulatory complexities of AI-powered medical devices with insights on the EU Artificial Intelligence Act: understand its horizontal scope and the implications for high-risk systems
English
On 1 August 2024, the legal landscape for medical devices containing artificial intelligence (AI) was changed beyond recognition by the entry into force of Regulation (EU) 2024/1689 (the AI Act). Unlike vertical regulations such as Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostics (IVDs), the AI Act is a horizontal regulation that applies to all products that qualify as an AI system. Such products range from radio equipment, toys and medical devices to general-purpose AI systems like ChatGPT and Claude.ai. Therefore, the AI Act must ensure that its one-size-fits-all approach works for the diverse range of AI systems it governs. This article by Cécile van der Heijden explores the consequences of the horizontal approach of the AI Act for medical devices and IVDs that also qualify as a high-risk AI system under the AI Act. It also highlights several issues requiring further clarification.
Specification: 21 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the May 2025 issue of the Journal of Medical Device Regulation.
