医疗器械法规（MDR, REGULATION (EU) 2017/745）分类要求

医疗器械法规（MDR, REGULATION (EU) 2017/745）分类要求

医疗器械分类

1、依据

依据(REGULATION (EU) 2017/745)附录VIII对医疗器械进行分类，共有22条分类规则：Rule 1 - Rule 4 非侵入性器械，Rule 5 - Rule 8 侵入性器械，Rule 9 - Rule 13有源器械，Rule 14 - Rule 22 特殊规则。

同时，制造商在进行医疗器械分类时可参考MDCG小组发布的如下分类界定指南文件进行：

◆ MDCG 2021-24 Guidance on classification of medical devices - 对MDR Article 2及MDR附录VIII的补充性解释

◆ MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

◆ Background note on the use of the Manual on borderline and classification for medical devices under the Directives

◆ Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v2 - 分类界定结果（每3个月更新一次）

◆ MDCG 2019-11 Guidance on Qualification and Classification of software in MDR and IVDR

此外，如对产品分类有议时可联系欧盟主管当局进行商讨；具体无法确定分类的器械申请分类界定的工作流程可参考“Helsinki Procedure for borderline and classification under MDR & IVDR”。