新冠病毒检测试剂CE技术要求
新冠病毒检测试剂CE技术文档目录列表（建议）：
1. 00 TCF Master File
2. 01 European Representative Agreement
3. 02 Harmonized standards list
4. 03.1 Instruction For Use
5. 03.2 Label
6. 04 Design and Manufacturing Information
7. 05 ER Checklist
8. 06 Risk analysis report
9. 07 Performance Analysis Related ResearchData
10. 08 Stability Evaluation Report
11. 09 Key raw materials Suppliers and BiosafetyDescription
12. 10 Clinical Evaluation Report
13. 11 Declaration of Conformity
