很多客户不愿意把产品技术文档交给欧代,或者会提供部分的产品技术文档,按照欧盟针对欧盟授权代表的指南文件MEDDEV2.5-10要求,欧代必须要保留至少以下的文件: 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 taken. 根据欧盟的法律要求,为了实现产品的可追溯行(traceability),制造商投放到欧盟市场的加贴了CE标志的产品必须标有制造商的名称和联络, 如果制造商来自欧洲经济区EEA(包括EU和以外的国家,其产品必须同时在标签(铭牌或包装)上标有制造商和制造商的欧盟授权代表的名称和联络。具体事宜,欢迎联系角宿咨询!
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