@article{shojaei_ai_2026,
title = {The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer},
author = {S. Shojaei and D. Yakar and N. Vellinga and V. Bozgo and T. Kwee and H. Huisman and J. P. M. Bonnici},
url = {https://doi.org/10.1007/s00261-026-05434-z},
doi = {10.1007/s00261-026-05434-z},
issn = {2366-0058},
year = {2026},
date = {2026-02-01},
urldate = {2026-02-01},
journal = {Abdominal Radiology},
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.},
keywords = {},
pubstate = {published},
tppubtype = {article}
}