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

Journal: Clinical chemistry and laboratory medicine
Published Date: May 28, 2025

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 Diagnostic Regulation (IVDR), ISO 15189:2022, and the Artificial Intelligence Act. An analysis of 89 MDSWs approved under the IVDR, derived from the European Database on Medical Devices (EUDAMED) reveals a diverse landscape of applications, ranging from digital pathology and molecular diagnostics to laboratory automation and clinical decision support. While Germany currently dominates the EU market for these devices, and the majority of approved MDSW remain non-AI driven and classified as low-risk, the increasing presence of AI-powered Class C devices underscores the growing potential of software in complex diagnostic scenarios. However, realizing the full potential of AI in laboratory medicine requires careful navigation of the evolving regulatory landscape. Key challenges persist, including defining intended use, ensuring robust clinical evidence, mitigating data bias, and establishing rigorous post-market surveillance. Balancing regulatory oversight with innovation is critical to fostering the development of trustworthy AI systems without stifling progress. As regulatory frameworks continue to evolve, establishing clear validation methodologies and transparent compliance pathways will be essential to unlocking the full potential of AI in laboratory medicine while ensuring the highest standards of safety and clinical effectiveness.

Authors

  • Hikmet Can Çubukçu
    Ankara University Stem Cell Institute, Interdisciplinary Stem Cells and Regenerative Medicine, Ankara, Turkey.
  • Guilaine Boursier
    CHU Montpellier, Department of Molecular Genetics and Cytogenomics, National Reference Laboratory of Autoinflammatory Diseases, French National Reference Center of Autoinflammatory Diseases and Amyloidosis (CeRéMAIA), IRMB, INSERM U1183, Univ Montpellier, Montpellier, France.
  • Solveig Linko
    Linko Q-Solutions, Helsinki, Finland.
  • Francisco A Bernabeu-Andreu
    Servicio Bioquímica - Análisis Clínicos Hospital Universitario Puerta de Hierro, Madrid, Spain.
  • Pika Meško Brguljan
    Department of Clinical Chemistry, University Clinic for Respiratory and Allergic Diseases, Golnik, Slovenia.
  • Katerina Tosheska-Trajkovska
    Department of Medical and Experimental Biochemistry, Faculty of Medicine, University Ss."Kiril and Metodij", Skopje, North Macedonia.
  • Duilio Brugnoni
    Central Laboratory for Clinical Chemistry, Spedali Civili, Brescia, Italy.
  • Neda Milinkovic
    Department of Medical Biochemistry, Faculty of Pharmacy, University of Belgrade, Belgrade, Serbia.
  • Andrea Padoan
    Department of Laboratory Medicine, University-Hospital of Padova, via Giustiniani 2, Padova 35128, Italy.
  • Marc Thelen
    SKML, Nijmegen, The Netherlands.

Keywords

No keywords available for this article.

External Resources

Popular Topics
Recent Journals