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 | 适用的标准清单 | 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的方案 (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 | 风险分析 | 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 | 设计图及产品技术规范 | |
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 | |
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