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欧盟医疗器械CE认证IVDR法规申请流程如下：
1、分析该器械的特点，确定它所属的指令范围
2、确定该器械的分类(风险分级)
3、选择相应的符合性评价程序
4、选择公告机构
5、确认适用的基本要求/有关的协调标准
6、确认该器械满足基本要求/协调标准, 并使证据文件化
7、欧盟授权代表。
8、欧洲注册。
9、对于需要公告机构评审的器械，通过公告机构的符合性程序
10、起草符合性声明并加贴CE标志
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