欧盟新法规下医用软件类产品分类界定思路探析
1.中国食品药品检定研究院，北京 102629；
2.广东省医疗器械质量监督检验所，广东 广州 510663；
3.国家药品监督管理局信息中心，北京 100163收稿日期: 2026-01-06
修回日期: 2026-03-02
录用日期: 2026-06-26
网络出版日期: 2026-06-29
Analysis on Classification and Definition of Medical Software Products Under the New EU Medical Device Regulations
Received date: 2026-01-06
Revised date: 2026-03-02
Accepted date: 2026-06-26
Online published: 2026-06-29
目的：探讨欧盟医疗器械新法规框架下医用软件类产品的界定与分类监管思路，为我国对医用软件的科学监管提供借鉴。方法：归纳梳理欧盟医疗器械新法规及相关指南文件中对医用软件类产品属性界定与分类判定的核心思路，开展系统性分析和对比研究。结果和结论：在国际上，欧盟首次提出了针对医用软件的专门分类规则，引入了“驱动或影响医疗器械（硬件）使用的软件”等新概念，优化了分类界定的决策步骤。按照该规则，医疗器械软件的产品属性和风险水平确定与其运行平台、所处位置无关，与是否独立运行无关，主要取决于其预期用途，并且将软件信息对决策的重要性和患者临床状况作为评价风险的重要考量因素。在分类界定中，增加了“不符合医疗器械定义但作为医疗器械管理的器械”的判定步骤；驱动或影响医疗器械（硬件）使用的软件作为医疗器械的附件或部件/组件被纳入医疗器械法规的监管范畴。此种监管新思路对我国医用软件类产品的分类界定工作具有一定的参考价值。
张春青
,
周良彬
,
江潇
,
曹啸
,
李萌
,
朱炯
,
路勇
.
欧盟新法规下医用软件类产品分类界定思路探析
Objective： This paper explores the rugulatory ideas for the definition and classification of medical software products under the new medical device regulations in the European Union， so as to provide a reference for the scientific regulation of medical software in China.Methods： Summarize the core principles of medical software attribute definition and classification under the new EU medical device regulations and guidance documents， and carry out systematic analysis and comparative study.Results and Conclusion： Internationally， the European Union first proposed dedicated classification rules for medical software， introduced new concepts including “software that drives or influences the use of medical devices （hardware）”， and optimized the decision tree for classification and definition of medical software . Under such rules， the product attributes and risk level of medical device software are irrelevant to its operating platform， location and independent operation， but mainly determined by its intended purpose. Meanwhile， the significance of software information to clinical decision-making and patients’ clinical conditions are taken as critical factors for risk evaluation. The revised decision tree adds the judgment procedures for “devices not conforming to the definition of medical devices but regulated as medical devices”. Software that drives or influences the use of medical devices （hardware） is covered by medical device regulations as accessories， parts or components of medical devices. Its new regulatory ideas have certain reference value for the classification and definition of medical software products in China.
Key words： Medical devices； ; Medical software； ; Qualification； ; Classification； ; Scientific regulation
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