The EU AI Act is a landmark regulation aimed at ensuring the safety, transparency, and accountability of AI systems. It establishes a risk-based classification of AI systems, ranging from low-risk to prohibited AI. High-risk AI systems, which include AI/ML-enabled medical devices, are subject to stringent compliance measures. The Act's obligations come into effect 36 months after its entry into force, i.e., by May 2027 for regulated medical AI systems. The regulation mandates comprehensive risk management, data governance, technical documentation, and post-market monitoring to ensure safety and effectiveness.
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.
【MORE】