人工智能医疗器械市场后监测法规:欧洲放射学学会的共识建议
Renato Cuocolo1, Diana Bernardini2, Daniel Pinto Dos Santos3
1Department of Medicine, Surgery, and Dentistry, University of Salerno, Baronissi, Italy. rcuocolo@unisa.it.
Insights into imaging
|December 12, 2025
概括
放射科医生必须了解欧盟对医疗器械的AI法规,因为共享安全监测责任和当前的法律模两可. 欧洲放射学学会为标准化AI部署和改善诊断成像中的临床反提供了建议.
科学领域:
- 医学成像技术 医学成像技术
- 监管科学 监管科学
- 医疗保健中的人工智能
背景情况:
- 人工智能作为医疗器械 (AIaMDs) 在诊断成像中日益集成.
- 现有的监管框架 (欧盟MDR,欧盟AI法) 缺乏针对AI组件的具体规定,造成了模两可.
- 放射科医生面临着关于这些法规及其责任的重大认识差距.
研究的目的:
- 提高临床从业人员对AIaMDs的欧盟法规的认识.
- 为AIaMD市场后监测 (PMS) 和市场后临床反 (PMCF) 提供实际指导和制定共同建议.
- 解决对高风险AI分类和放射学安全部署的清晰指导方针的需求.
主要方法:
- 修改后的Delphi程序涉及16名领域专家 (14名小组成员).
- 基于欧盟MDR和AI法案,为AIaMD PMS和PMCF制定共享建议.
- 对部署者 (放射科医生) 和提供者 (供应商) 的相关法规的概述.
主要成果:
- 确定了对AIaMD法规和安全部署实践的明确指导方针的迫切需要.
- 为AIaMD PMS和PMCF制定了一系列建议,旨在规范实践.
- 突出了AIaMD安全的共同责任,涉及软件提供商和放射科医生.
结论:
- 在诊断成像中,ESR建议是提高AIaMD部署在诊断成像中的一致性的一个基本步骤.
- 这些建议为导航AIaMD挑战的医生提供了关键的参考.
- 弥合意识差距对于安全的AI部署和医疗成像中的有效临床反至关重要.
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