新冠体外诊断试剂德国白名单怎么申请周期多久

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 re (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