CHINESE JOURNAL OF MEDICINAL GUIDE >

2026 , Vol. 28 >Issue 5: 522 - 522-527

DOI: https://doi.org/10.1009-0959.2026.050029

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

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  • 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 date: 2026-01-06

  Revised date: 2026-03-02

  Accepted date: 2026-06-26

  Online 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

Cite this article

ZHANG Chunqing, ZHOU Liangbin, JIANG Xiao, CAO Xiao, LI Meng, ZHU Jiong, LU Yong .

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

[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2026 , 28(5) : 522 -522-527 . DOI: 10.1009-0959.2026.050029

References

      ［1］ 张一帆，张泽瑞，董敬，等.大模型时代下的医疗人工智能技术进展与挑战［J］.中国医学装备，2024，21（6）：189-194.

         ［2］  王浩，孟祥峰，林晓兰，等.人工智能医疗器械数据集质控解决方案［J］.医疗卫生装备，2023，44（2）：12-15.

         ［3］  孟祥峰，张超，唐桥虹，等.手术机器人性能评价方法的探讨［J］.中国医疗设备，2020，35（9）：18-21.

         ［4］  江潇，张春青，戎善奎，等.数字疗法软件产品分类管理研究［J］.中国医疗器械杂志，2023，47（5）：482-486.

         ［5］  国家药品监督管理局.国家药监局关于发布人工智能医用软件产品分类界定指导原则的通告（2021年第47号）［EB/OL］.（2021-07-01）［2026-01-06］.https：//www.nmpa.gov.cn/ylqx/ylqxggtg/20210708111147171.html.

         ［6］  国家药品监督管理局医疗器械技术审评中心.移动医疗器械注册审查指导原则（2025年修订版）［EB/OL］.（2025-04-29）［2026-01-06］.https：//www.cmde.org.cn//xwdt/shpgzgg/gztg/20250507101948125.html.

         ［7］  张建楠，李莹莹，周佳卉，等.人工智能独立医用软件监管研究［J］.中国工程科学，2022，24（1）：198-204.

         ［8］  Medical Device Coordination Group. Guidance on Qualification and Classification of Software in Regulation （EU） 2017/745-MDR and Regulation （EU） 2017/746-IVDR［EB/OL］.（2025-06-01）［2026-01-06］.https：//health.ec.europa.eu/document/download/b45335c5-1679-4c71-a91c-fc7a4d37f12b_en？ filename=mdcg_2019_11_en.pdf.

         ［9］  European Commission. Guidelines on the Qualification and Classification of Stand alone Software used in Healthcare within the Regulatory Framework of Medical Devices［EB/OL］.（2016-07-01）［2026-01-06］.https：//ec.europa.eu/docsroom/documents/17921/attachments/1/translations.

         ［10］ Council of the European Union. Regulation （EU） 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices， Directiveamending 2001/83/EC， Regulation （EC） No 178/2002 and Regulation （EC） No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC［EB/OL］.（2024-07-09）［2026-01-06］.https：//eur-lex.europa.eu/legal-content/EN/TXT/？uri=OJ：L：2017：117：TOC.

         ［11］ 张春青，周良彬，王越，等.欧盟新法规医疗器械分类管理思路变化的研究分析［J］.中国医疗器械杂志，2018，42（3）：202-205.

         ［12］ International Medical Device Regulators Forum. Software as a Medical Device： Possible Framework for Risk Categorization and Corresponding Considerations［EB/OL］.（2014-09-18）［2026-01-06］.https：//www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-140918-samd-framework-risk-categorization-141013.pdf.

         ［13］ Medical Device Coordination Group. MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation （EU） 2017/746［EB/OL］.（2025-03-18）［2026-01-06］.https：//health.ec.europa.eu/latest-updates/update-mdcg-2020-16-rev4-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2025-03-18_en.

         ［14］ 国家药品监督管理局.医疗器械分类目录［EB/OL］.（2017-08-31） ［2026-01-06］.https：//www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20170904150301406.html.

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