CE

生產商在向歐洲經濟區(EEA) 出口醫療器械之前都必須確保嚴格符合相關適用指令(Directive) 的基本要求(Essential Requirements)，向主管當局進行注冊申報 。

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

目前適用于醫療器械的相關指令如下：

有源植入醫療器械指令( AIMDD 90/385 EEC )

醫療器械指令( MDD 93 /42/ EEC )

體外診斷醫療器械指令( IVDD 98 / 79 / EC )

針對MDD以及AIMDD 的修訂(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).

歐盟醫療器械相關指令，向制造商提供了多種符合性途徑。制造商可以基于產品的風險進行適當的選擇。

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

appropriate route based on the risk of product.

IVDR MDR

我們的服務

Services

◆ 產品分類

 Product Classification

◆ 協助選擇合理的認證途徑

 Assist you in selecting appropriate conformity route

◆ 協助選擇合適的公告機構

 Assist you in selecting appropriate notified body

◆ 推薦測試機構

 Recommendation of testing laboratories

◆ 編寫CE技術文件/設計文檔

 Prepare CE Technical File / Design Dossier

◆ 協助完成臨床評估

 Assist you in completing clinical evaluation report

◆ 歐盟代理人服務

 EU Representative Service

醫療器械CE認證咨詢與服務

Medical Device CE certification consultation