我們知道,歐盟醫藥器械監活動中,很大一部門工作由歐盟授權的第三方公告機構實施。如公告機構被撤銷資質,企業醫療器械CE證書會被吊銷嗎?答案可能和我國管理體系認證要求存在差異。
我們知道,歐盟醫藥器械監活動中,很大一部門工作由歐盟授權的第三方公告機構實施。如公告機構被撤銷資質,企業醫療器械CE證書會被吊銷嗎?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by the notified body up to that point, until such time as demonstration can be made that the certificates should be withdrawn.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(公告機構)的授權,不會影響被公告機構出具的證書,直到證明該證書應被撤回為止。