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PubMed

The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer.

PMID: 41714355 · 2026

JournalAbdominal radiology (New York)
Year2026
PMID41714355

Abstract

To clarify overlapping post-market obligations under the EU Artificial Intelligence Act (AIA) and EU Medical Device Regulation (MDR) for high-risk artificial intelligence (AI) Software as a Medical Device (SaMD), and to map the regulatory landscape for manufacturers, healthcare providers, AI providers, and AI deployers. We conducted a qualitative doctrinal legal analysis of post-market provisions in the AIA and MDR, using a case study of a high-risk Class III AI SaMD for prostate cancer radiolog

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