新冠体外诊断试剂德国白名单怎么申请周期多久？体外诊断试剂，特别是新冠诊断试剂从去年到今年一直是热门产品，多数企业希望取得CE认证并将产品销往欧盟市场，本文为大家科普新冠诊断试剂CE认证技术文件有哪些？
新冠诊断试剂CE认证技术文件有哪些？
我们先来了解Part A部门文件有哪些：
1.Manufacturer Information (Name, Address, Telephone…)
2.European Authorized Representative Agreement
3.Declaration Of Conformity
4.Approved Certificate
5.Product Description (including Product group/ plannedvariations)
6.Classification (according 98/79/EC IVDD Annex II)
7.Technical Information
8.1Labels
9.2Iinstruction For Use
10.Conform Essential Requirements (98/79/EC IVDD Annex I)
11.Risk Management Report
12.Applied Standards
13.Clinic Evaluation Report
14. Post-Marketing Clinical Follow-Up Plan
15.Vigilance Syste
