This paper examines the regulatory framework governing AI-based diagnostic systems under EU law. It analyzes how such systems are classified as high-risk AI under the EU Artificial Intelligence Act — a classification that derives directly from their risk classification under the Medical Device Regulation — and what requirements apply to their market approval. The paper further shows that the two frameworks do not operate in parallel: the AI Act is absorbed into the existing MDR conformity assessment procedure, adding AI-specific requirements addressing data governance, human oversight, and continuous learning without creating redundant compliance obligations. Primary sources include the EU AI Act, the MDR, and the joint guidance document MDCG 2025-6.
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- Marlon Müller (Autor), 2026, AI-Powered Medical Diagnostics under Dual Regulation, Múnich, GRIN Verlag, https://www.grin.com/document/1723862
