Çubukçu Hikmet Can, Boursier Guilaine, Linko Solveig, Bernabeu-Andreu Francisco A, Meško Brguljan Pika, Tosheska-Trajkovska Katerina, Brugnoni Duilio, Milinkovic Neda, Padoan Andrea, Thelen Marc
Rare Diseases Department, General Directorate of Health Services, Turkish Ministry of Health, Ankara, Türkiye.
Department of Medical Biochemistry, Sincan Training and Research Hospital, Ankara, Türkiye.
Clin Chem Lab Med. 2025 May 28. doi: 10.1515/cclm-2025-0482.
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.
人工智能（AI）正在迅速改变检验医学，影响医疗设备和医疗保健实践。尽管取得了这些进展，但基于人工智能的医疗设备软件（MDSW）在法规合规方面引入了新的复杂层面。本文概述了MDSW和人工智能驱动的MDSW的监管格局，明确了检验专业人员和制造商在《体外诊断医疗器械法规》（IVDR）、ISO 15189:2022和《人工智能法案》下的责任。对从欧洲医疗器械数据库（EUDAMED）获取的89款根据IVDR批准的MDSW进行的分析显示，其应用领域广泛，从数字病理学和分子诊断到实验室自动化和临床决策支持。虽然德国目前在欧盟这些设备市场占据主导地位，且大多数获批的MDSW仍非人工智能驱动且被归类为低风险，但人工智能驱动的C类设备的日益增多凸显了软件在复杂诊断场景中的巨大潜力。然而，要在检验医学中充分发挥人工智能的潜力，需要谨慎应对不断演变的监管格局。关键挑战依然存在，包括定义预期用途、确保有力的临床证据、减轻数据偏差以及建立严格的上市后监测。在监管监督与创新之间取得平衡对于促进可靠人工智能系统的发展而不阻碍进步至关重要。随着监管框架不断演变，建立明确的验证方法和透明的合规途径对于释放人工智能在检验医学中的全部潜力、同时确保最高安全和临床有效性标准至关重要。
