无源医疗器械CE技术文档和CE设计档案材料指南(中英文 也是极好的).doc

无源医疗器械技术文件和设计文档指南 Whereas the term “Technical File“ is used for Medical Devices of class I, class IIa and class IIb, the term “Design Dossier“ is used for the class III products. 标题中的“技术文件”适用于I类，IIa类,IIb类医疗器械，“设计文档”适用于III类医疗器械。 Technical Files are retained in the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body. Part B of the Technical File may be available at the manufacturer only. 技术文件是保留在制造商或授权代表单位的主管部门和认证机构。部分技术文件B部分只保留在制造商处。 Whereas Design Dossiers have to be submitted to the Notified Body for review prior to CE-Marking of the product (use form Application for CE Conformity Assessment (Product)MED_F_03.03). We will assign a project manager who will entrust one or more further experts with the review of particular modules. All experts are at your disposal directly or indirectly through the project manager. After successful review, the Notified Body issues a design examination certificate according to Annex II.4 of the Council Directive certifying compliance with the relevant provisions of Annex I of the MDD. 设计档案材料已被提交到公告机构用于需要CE认证前的产品审查（用CE合格评定（产品）MED_F_03.03规定的格式）。我们将委派一个项目经理，他将委托一个或多个资深专家审查特定的模块。所有专家会直接或通过项目经理间接与你接触，在成功的审查后，公告机构会按照MDD法规附件I和附件II.4相关规定签发检验证书。 Article 5 of the Council Directive describes consideration of the European harmonized standards by the manufacturer in order to demonstrate compliance with the Essential Requirements.This aspect is even more important as International Standard Organizations have adopted European Norms (and vice versa) and demonstrating compliance with these standards could be very helpful in international mutual recognition of the CE-Marking process. 理事会指令5描述了制造商要遵守的欧洲统一标准，以证明附合基本要求，这方面更重要的是为国际标准组织已经通过了欧洲规范（反之亦然），并且遵守这些标准可能非常有助于国际的相互承认在CE认证过程中。 It is not necessary to include all documents in the Design Dossier which have already been subject to an ISO / EN / MDD Audit by the Notified Body. Examples of documents not necessary to be included are Qua