我們知道，歐盟醫(yī)藥器械監(jiān)活動(dòng)中，很大一部門工作由歐盟授權(quán)的第三方公告機(jī)構(gòu)實(shí)施。如公告機(jī)構(gòu)被撤銷資質(zhì)，企業(yè)醫(yī)療器械CE證書會(huì)被吊銷嗎？答案可能和我國管理體系認(rèn)證要求存在差異。

按照2016/C 272/01 Commission Notice — The ‘Blue Guide’ on the implementation of EU products rules 2016（見附件第89頁）條款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by the notified body up to that point, until such time as demonstration can be made that the certificates should be withdrawn.

暫停或撤回（公告機(jī)構(gòu)）的授權(quán)，不會(huì)影響被公告機(jī)構(gòu)出具的證書，直到證明該證書應(yīng)被撤回為止。