公告机构被撤销资质,企业医疗器械CE证书会被吊销吗?

我们知道,欧盟医药器械监活动中,很大一部门工作由欧盟授权的第三方公告机构实施。如公告机构被撤销资质,企业医疗器械CE证书会被吊销吗?答案可能和我国管理体系认证要求存在差异。

医疗器械CE证书.jpg

按照2016/C 272/01 Commission Notice — The ‘Blue Guide’ on the implementation of EU products rules 2016(见附件第89页)条款5.3.4的要求:

Without prejudice to sectoral specificities, the suspension or withdrawal of a notification does not affect certificates issued by the notified body up to that point, until such time as demonstration can be made that the certificates should be withdrawn.

暂停或撤回(公告机构)的授权,不会影响被公告机构出具的证书,直到证明该证书应被撤回为止。

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