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