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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
Abstract
The aim of this review is not to catalogue every application of clinical AI, but to summarise the regulatory pathway linking intended purpose, qualification and classification, evidence requirements, governance, risk management and post-market surveillance under the European framework. When can a clinically promising algorithm be defended not only as software that performs well in development, but as software that can sustain a medical claim, survive conformity assessment and remain governable after deployment? That is where the regulatory logic of the Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR) and the AI Act converge. This review therefore treats evidence, governance and post-market surveillance not as separate downstream chapters, but as parts of the same pathway that begins with intended purpose and ends only when use in routine care remains controllable over time.
Keywords: artificial intelligence; medical device regulation; software as a medical device; clinical validation; risk management; post-market surveillance
©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.