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The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer
0
Zitationen
7
Autoren
2026
Jahr
Abstract
The AIA and MDR share common ground in some post-market areas but also diverge in key responsibilities. To ensure safe and effective use of high-risk AI in healthcare, clearer coordination between the two frameworks is needed, especially in areas such as human oversight and system modification, where current guidance remains limited.
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