申请医疗器械CE认证时常说到欧代

依据欧盟医疗器械CE认证法规文件MDD 93/42/EEC、IVDD 98/78/EC和MDR 2017/745/EU ，非欧盟境内的医疗器械生产商必需选择一位于欧盟境内的代理商、经销商或者独立的授权代表作为他们在欧盟境内的授权代表。欧代为医疗器械生产商扮演的核心角色是法律事务代表。 

二、医疗器械CE认证，哪些文件要保存在欧代处？

依照欧盟针对欧盟授权代表的指南文件MEDDEV2.5-10请求，医疗器械CE认证企业（I类为CE符合性声明）的欧代处必需要保存至少以下的文件：

i) Declaration of conformity；
ii) Copy of the label, packaging and instructions for use (in all languages requested by the countries where the device is marketed)；
iii) Notified Body certification (where relevant)；
iv) Post market surveillance process and data, vigilance reports and complaints, processes and data；
v) Technical documentation relevant to market surveillance investigation being undertaken by the Member State；
vi) Relevant clinical data / notification；
vii) Details of any distributors / suppliers putting the CE marked devices on the market；
viii) Incident reports and corrective actions take.