Humiss欧盟授权代表协议-IVD3.11版 D6.pdf

Version:HM-v3.11 EU RepresentativeAgreement 欧代协议 o Document N .: H-YQ-IVD Party A hereby appoints Party B as the authorized European Representative for their in vitro diagnostic medical device (IVD) with CE mark, Party B accepts the appointment to be the authorized European Representative for Party A in the market of European Union (EU), EEA and Switzerland, Turkey,both parties enterthis agreement as follow,the appointed product categories set out inAnnex I. 甲方任命乙方为CE体外诊断医疗器械产品欧盟授权代表，乙方接受甲方任命为甲方在欧盟、EEA、 瑞士、和土耳其市场的CE体外诊断医疗器械产品的授权代表,双方签署下列协议，委托的产品类别见 附件I。 1 Obligations and Liabilities of Party A 甲方职责和义务 1.1 Party A assures to provide the updated technicalfiles of each product category with CE markto Party B. If Party A cannot provide the required technicalfile to Party Bwithin 30 days after approval of CEcertification or before using CE markfor “self-declaration” products,this agreement will be terminated automatically, Party A should take on any aftereffect by itself.The technicalfiles should be the electronic copy (PDF/WORD/JPG/ vision),the written copy would be submitted if required by the competent authority. Detail of the requirements of the submitted files as following: 甲方确保在认证结束后向乙方提供每一 大类带CE标志产品的、最新的技术文档。如果甲方在认证结束取得证书之后的30天内，或者 “自我声明”产品在使用CE标记之前，仍然没有提供给乙方符合要求的CE技术文档的，本协议 自动失效，甲方承担由此而引起的所有后果。甲方必需提交电子文件，文件可以是 PDF/WORD/JPG/格式的任何一种。书面文件只有在欧盟当局需要审核时才提交乙方。所提 交文档内容的要求如下： ­ Declarationof conformity, 符合性声明 ­ Copy of the label, packaging and instructions for use (in all languages requested by the countries where the device is marketed), 标签、包装、说明书副本 （所有上市国家要求 的语言的版本） ­ Notified Body certification (where relevant), 公告机构证书 （适用时） ­ Post market surveillance process and data,vigilance