我們知道，歐盟醫藥器械監活動(dòng)中，很大一部門(mén)工作由歐盟授權的第三方公告機構實(shí)施。如公告機構被撤銷(xiāo)資質(zhì)，企業(yè)醫療器械CE證書(shū)會(huì )被吊銷(xiāo)嗎？答案可能和我國管理體系認證要求存在差異。

按照2016/C 272/01 Commission Notice — The ‘Blue Guide’ on the implementation of EU products rules 2016（見(jiàn)附件第89頁(yè)）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by the notified body up to that point, until such time as demonstration can be made that the certificates should be withdrawn.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?；虺坊兀ü鏅C構）的授權，不會(huì )影響被公告機構出具的證書(shū)，直到證明該證書(shū)應被撤回為止。