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PubMed

Regulating the future of laboratory medicine: European regulatory landscape of AI-driven medical device software in laboratory medicine.

PMID: 40440607 · 2025

JournalClinical chemistry and laboratory medicine
Year2025
PMID40440607

Abstract

Artificial intelligence (AI) is rapidly transforming laboratory medicine, impacting medical devices and healthcare practices. Despite these advancements, AI-based medical device software (MDSW) introduces a new layer of complexity in regulatory compliance. This paper outlines the regulatory landscape for MDSW and AI-driven MDSW, clarifying the responsibilities of laboratory professionals and manufacturers under the

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