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
IDVEAR公众号
.jpg "62500c9c1e414(1).jpg")
Tel：0755-33509057
Adress：Building 2, Building B, Building 103-110, Baoxin Science and Technology Park Factory Area, No. 9 Guangyuan Fifth Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Province.
E-mail：hitolin@ivdear.com
IVDEAR can undertake the whole process of technical guidance and services such as prospective clinical, who Eul, variant virus research (Delta, Omicron ba.1, ba.2), IVDD CE, ivdr CE, Australian TGA, British CTDA, European HSC common list, European service, British service, etc.
If you have products that have been tested and certified or want to know more about them, please contact IVDEAR！
Popular keywords：UK authorised representative CTDA registration HSC EU common list Canada cmdcas certification Canadian del certification Australian TGA certification Registered in Hong Kong Medical device certification Variant strain test Who Eul application IVDD CE certification IVDR CE认证 EU authorized representative SRN registration Ukca certification
友 情 链 接：国瑞质量检验中心
Copyright © 艾维迪亚（深圳）医疗科技有限公司 All rights reserved