CHINESE JOURNAL OF MEDICINAL GUIDE ›› 2026, Vol. 28 ›› Issue (5): 522-522-527.doi: 10.1009-0959.2026.050029

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Analysis on Classification and Definition of Medical Software Products Under the New EU Medical Device Regulations

ZHANG Chunqing1， ZHOU Liangbin2， JIANG Xiao1， CAO Xiao1， LI Meng3， ZHU Jiong1*， LU Yong1*   

  1. 1.National Institutes for Food and Drug Control， Beijing 102629， China；
    2.Guangdong Medical Device Quality Surveillance and Test Institute， Guangdong Guangzhou 510663， China；
    3.Center for Information， National Medical Products Administration， Beijing 100163， China
  • Received:2026-01-06 Revised:2026-03-02 Accepted:2026-06-26 Online:2026-05-28 Published:2026-06-29

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Abstract:

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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