CE技术文档清单(中英文)[2P][159KB]

Contents of Technical File Contents Notes Part A 1 Name, Postal Address of Manufacturer /EU Representive 2 A listing of all manufacturing sites covered by the quality system 3 Product description 3.1 Product name, classification of the device and accessories 3.2 List of accessories (if applicable) 3.3 Specification, model and article numbers 3.4 Chosen conformity assessment path 3.5 Intended use 3.6 Integral parts of the sales unit 3.7 A brief product history (including existing regulatory approvals) 4 List of harmonized standards Satisfy the Annex I 5 Essential Requirements checklist the solutions adopted to satisfy the Essential Requirements (template, English version) 6 Overall manufacturing and inspection plan of the product 7 Risk analysis EN ISO 14971:2007 (template, English version) 8 Clinical report Detailed see in Part B 9 Labelling, inl. Product labels and package labels (English version) 10 Instruction for use, patient information, advertising material (English version) 11 Declaration of conformity (template, English version) Part B 12 Information concerning the quality system specific to the product 13 Detailed descriptions of the product 13.1 Design drawings and product specifications 13.2 Packaging and specification (English version) 13.3 Description of the manufacturing processes Drawings, qualification, Labeling control, Traceability,Product and environmental bioburden particles, Pyrogene testing, Preventive monitoring of processes (i.e. SPC), Viral- Prion Desactivation steps etc. 13.4 Raw materials and suppliers 14 Test, verification and evaluation report 14.1 Sterile method and validation IQ/OQ/PQ 14.2 Packaging verification (if applicable) Incl. package expired date 14.3 Chemical, physical and biology test, verification and evaluation report 15 Clinical datas The critical report must be in Part A of the Technical File. The publications quoted in the report must be available in Part B of the Technical File as original documents, reprints or copies. 15.1 Preclinical Evaluation, Expert Opinions 15.2 Clinical plan 15.3 Clinical datas 15.4 Clinical Summary, Expert Opinions 15.5 Clinical report 15.6 Relevant Literature 技 术 文 档 的 内 容 内 容 备 注 Part A 1 制造商和 欧洲代表的名字、地址 2 质量体系所涉及的全部制造场所清单 3 产品描述 3.1 产品名字、器械及附件的分类 3.2 产品附件清单（适用时） 3.3 规格、型号及货号 3.4 符合性评价路径 3.5 预期用途描述 3.6 主要的销售单元（适用时） 3.7 简要的产品历史（包括现有的管理审批） 4 适用的清单 符合医疗器械指令附录 I 5 基本要求检查表 符合医疗器械指令附录 I的 (有固定模板，需提交英文文件) 6 产品的总体生产或质量控制方案 7 风险 EN ISO 14971:2007 有固定模板，需提交英文文件 8 临床报告 详细的临床数据见 Part B 9 标签，包括产品标签、包装标签 (需提交英文文件) 10 使用说明、患者信息、广告材料 (需提交英文文件) 11 符合性声明 (有固定模板，需提交英文文件) Part B 12 与产品有关的质量体系的信息 13 详细的产品描述 13.1 图及产品技术 13.2 包装条件及规格 (需提交英文文件) 13.3 生产过程描述 包括流程图、资格确认、标签控制、 追溯性、产品及生产环境控制、过程 的预防监控、消毒或防护过程等 13.4 原材料和供方 14 试验、验证及评估报告 14.1 灭菌方法和验证的概述，灭菌证书（适用时） IQ/OQ/PQ 14.2 包装验证（适用时） 包括包装有效期验证 14.3 化学、物理和生物学试验、验证或评估报告 15 临床数据 临床评价报告必须包含在技术文档的 第一部分中，报告中引用的出版物必 须以原始文件、重印本或复印件的形 成在即数文档的第二部分提供 15.1 临床前评估，专家意见 15.2 临床方案 15.3 临床数据 15.4 临床总结，专家意见 15.5 临床报告 15.6 相关文献