出口欧盟的产品，其批生产记录保存期限需多久？

惠惠cute

公司有出口欧盟的医疗器械和体外诊断试剂，想问各位老师MDR、IVDR或者欧盟有没有文件规定产品生产记录需要在公司保存几年？

这个下雨天

CHAPTER III
ADMINISTRATIVE PROVISIONS
6. The manufacturer or, where the manufacturer does not have a registered place of business in a Member State,
it's authorised representative shall, for a period ending no sooner than 10 years after the last device has been
placed on the market, keep at the disposal of the competent authorities:
— the EU declaration of conformity,
— the documentation referred to in the fifth indent of Section 2.1. and, in particular, the data and records
arising from the procedures referred to in point (c) of the second paragraph of Section 2.2.,
— information on the changes referred to in Section 2.4.,
— the documentation referred to in Sections 4.2. and point (b) of Section 5.1., and
— the decisions and reports from the notified body as referred to in this Annex.
按照IVDR法规要求，至少保存到最后一个设备欧盟市场上市流通后10年。

隐隐约约

MDR的要求：
在最后一个器械上市至少10年内，制造商或其授权代表（若制造商在成员国尚无注册营业场所），按照主管机构指示，保管以下文件：
-欧盟符合性声明；
-第2.1节第五段所述的文件，尤其是第2.2节第2项（c）点所述流程所产生的数据和记录；
-第2.4节所述变更如的信息。
-第4.2节和第5.1节（b）点所述的文件；以及
-本附录所述的公告机构决定和报告。