欧盟MDR体系下医美器械产品监管思路探析
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
收稿日期: 2025-07-23
修回日期: 2025-09-19
录用日期: 2025-11-15
网络出版日期: 2025-12-17
Research on the Regulatory Approach of Medical Aesthetic Devices under the EU MDR System
Received date: 2025-07-23
Revised date: 2025-09-19
Accepted date: 2025-11-15
Online published: 2025-12-17
张春青
,
周良彬
,
王越
,
施闰
,
朱炯
,
路勇
.
欧盟MDR体系下医美器械产品监管思路探析
Objective： To explore the regulatory approach and characteristics of medical aesthetic devices under the framework of the EU Medical Devices Regulation （MDR）， and to provide reference for the scientific supervision of similar products in China.Methods： Collate and analyze a series of materials and data regarding the regulatory requirements， classification and definition principles， as well as product registration status of medical aesthetic devices in MDR and its supporting documents， so as to examine the regulatory logic and working approaches.Results and Conclusion： Under the MDR framework， the EU has issued a series of supporting regulations and guideline documents， establishing a relatively comprehensive regulatory system. Based on the consideration of risk similarity， MDR includes "non-medical purpose" products with functions and risks similar to medical devices into Annex XVI in the form of a published list， and regulates them as medical devices. Meanwhile， considering the differences between the six categories of products in Annex XVI and ordinary medical devices， a mechanism is established where the Common Specifications （CS） must take effect before MDR applies to these products. The regulatory attributes of such products are determined comprehensively by the product descriptions in MDR Annexes and the applicable product scope specified in CS acts， further confirming the approach of regulating by product groups. In view of the particularity of the products， MDR proposes targeted risk management requirements based on usage scenarios. It conducts case-by-case analysis for subcategories of products， and decides whether to include them in supervision by comprehensively considering product risks and the maturity of regulatory measures.
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