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

Journal

Clinical Chemistry and Laboratory Medicine (CCLM)

Date Issued

2025-05-28

Author(s)

Çubukçu, Hikmet Can

Boursier, Guilaine

Linko, Solveig

Bernabeu-Andreu, Francisco A.

Meško Brguljan, Pika

Brugnoni, Duilio

Milinkovic, Neda

Padoan, Andrea

Thelen, Marc

DOI

10.1515/cclm-2025-0482