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. 2024 Sep 6;7(1):237.
doi: 10.1038/s41746-024-01232-3.

Navigating the EU AI Act: implications for regulated digital medical products

Mateo Aboy  1   2 , Timo Minssen  3   4 , Effy Vayena  5
Affiliations

Navigating the EU AI Act: implications for regulated digital medical products

Mateo Aboy et al. NPJ Digit Med. .

Abstract

The newly adopted EU AI Act represents a pivotal milestone that heralds a new era of AI regulation across industries. With its broad territorial scope and applicability, this comprehensive legislation establishes stringent requirements for AI systems. In this article, we analyze the AI Act’s impact on digital medical products, such as medical devices: How does the AI Act apply to AI/ML-enabled medical devices? How are they classified? What are the compliance requirements? And, what are the obligations of ‘providers’ of these AI systems? After addressing these foundational questions, we discuss the AI Act’s broader implications for the future of regulated digital medical products.

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Conflict of interest statement

The authors declare no competing interests.

References

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    1. FDA. Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. https://www.fda.gov/medical-devices/software-medical-device-samd/artific... (2022).
    1. Aboy, M., Crespo, C. & Stern, A. D. Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA’s De Novo pathway. NPJ Digit Med.24, 1–8 (2024). - PMC - PubMed
    1. in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. (ed European Parliament and Council) (2017).
    1. in Regulation of the European Parliament and of the Council laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act) (ed European Parliament and Council) (2024).

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