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Review Article Volume 11 Issue 1
Regulatory Pathway and Evidence Requirements for Clinical Artificial Intelligence as Medical Device Software (MDSW/SAMD) Under the MDR And the AI Act
Marco Viscovo, Marcella Marletta, Roberto Verna
Received: July 14, 2026 | Published: August 7, 2026
Citation: Viscovo M, Marletta M, Verna R. Regulatory Pathway and Evidence Requirements for Clinical Artificial Intelligence as Medical Device Software (MDSW/SAMD) Under the MDR And the AI Act. Int Clin Pathol J. 2026;11(1):33-38. DOI: 10.15406/icpjl.2026.11.00225
©2026 Viscovo, et al. This is an open access article distributed under the terms of the, which permits unrestricted use, distribution, and build upon your work non-commercially.