医疗器械CE认证所需资料

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医疗器械申请CE认证产品的相关文件要求（ 技术文档TCF内容，英文）

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1．产品的总体描述General descript of the device

2．预期用途描述Description of intended use

3．产品等级划分，所选分类规则、理由Class of device, chosen classification rule andjustification

4．附件描述（如适用）Description of accessories (if applicable)

5．共同作用药物描述（如适用）Description of incorporated pharmaceuticalsubstances (if applicable)

6．所用动物组织描述（如适用）Description of utilized tissues of animal origin(if applicable)

7．计划制造方法Planned production methods

8．制造过程各阶段及最终的检验测试Description of checks during and at the end ofproduction

9．基本要求事项对照Responses to essential requirements

10．适用标准清单List of applied standards

11．风险分析Risk analysis

12．材质说明Specification of materials

13．产品外观及内部结构（包括电路图等）Drawings and schematics

14．标识Labeling

15．包装描述Description of packaging

16．使用说明Instructions for use

17．寿命和/或保存期限Lifetime and/or shelf-life

18．灭菌有效性确认（如适用）Sterilization validation (if applicable)

19．测试报告（电气部分、机械部分及生物相容性等方面）

Test reports(electrical/mechanical/biocompatibility etc.)

20．临床数据Clinical data