欧洲CE认证咨询

生产商在向欧洲经济区(EEA) 出口医疗器械之前都必须确保严格符合相关适用指令(Directive) 的基本要求(Essential Requirements)，向主管当局进行注册申报 。

Medical device manufacturers shall ensure that products are complied with Essential Requirements of related applicable Directive prior to marketing in European Economic Area (EEA).

目前适用于医疗器械的相关指令如下：

有源植入医疗器械指令( AIMDD 90/385 EEC )

医疗器械指令( MDD 93 /42/ EEC )

体外诊断医疗器械指令( IVDD 98 / 79 / EC )

针对MDD以及AIMDD 的修订(2007/47/ EEC)

The directives include:

Active Implantable Medical Devices Directive (AIMDD 90/358/EEC).

Medical Device Directive (MDD 93/421EEC).

In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC).

Amendment to MDD and IVDD (2007/47/EEC).

欧盟医疗器械相关指令，向制造商提供了多种符合性途径。制造商可以基于产品的风险进行适当的选择。

Each directive of medical device provides many conformity routes. Manufacturers can select the

appropriate route based on the risk of product.

IVDR MDR

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◆ 产品分类

 Product Classification

◆ 协助选择合理的认证途径

 Assist you in selecting appropriate conformity route

◆ 协助选择合适的公告机构

 Assist you in selecting appropriate notified body

◆ 推荐测试机构

 Recommendation of testing laboratories

◆ 编写CE技术文件/设计文档

 Prepare CE Technical File / Design Dossier

◆ 协助完成临床评估

 Assist you in completing clinical evaluation report

◆ 欧盟代理人服务

 EU Representative Service