The Renewed EU Legal Framework for Medical AI
Abstract
The use of artificial intelligence (AI), along with its possible risks and promised benefits, has attracted much attention, filling pages of scientific literature. At the same time, the legal literature has been busy outlining the legal framework applicable to AI systems used in medicine: mainly the Medical Device Regulation (MDR) and the AI Act. The literature has already pointed out the gaps in this legal framework, emphasising its limited significance for AI systems classified as ‘minimal risk’ under the AI Act. This paper builds upon this literature and overviews the broader product safety framework applicable to medical AI. In this light, while the MDR remains the main co-regulator of medical AI, numerous other regulations interact with the AI Act while regulating medical AI. Starting from the shortcomings of the relationship between MDR and the AI Act, this paper maps the product safety framework applicable to medical AI. Referring in particular to other regulations within the EU New Legislative Framework, it offers the safety framework relevant for AI systems classified for different reasons as minimal risk under the AI Act.
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