我們知道,歐盟醫(yī)藥器械監(jiān)活動(dòng)中,很大一部門(mén)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(xiāo)資質(zhì),企業(yè)醫(yī)療器械CE證書(shū)會(huì)被吊銷(xiāo)嗎?答案可能和我國(guó)管理體系認(rèn)證要求存在差異。
我們知道,歐盟醫(yī)藥器械監(jiān)活動(dòng)中,很大一部門(mén)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(xiāo)資質(zhì),企業(yè)醫(yī)療器械CE證書(shū)會(huì)被吊銷(xiāo)嗎?答案可能和我國(guó)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(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by the notified body up to that point, until such time as demonstration can be made that the certificates should be withdrawn.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(shū),直到證明該證書(shū)應(yīng)被撤回為止。