摘要
2017年5月,欧盟官方期刊(Official Journal of the European Union)正式发布了医疗器械法规(MDR,EU2017/745)和体外诊断医疗器械法规(IVDR,EU 2017/746),法规对公告机构提出了更为严格的要求。本文重点介绍欧盟法规对公告机构的管理要求。
May2017,Official Journal of the European Union Officially issued the regulations on medical devices(MDR,EU2017/745)and regulations on In vitrodiagnostic medical devices(IVDR,EU2017/746).The new regulations are more stringent on the requirements of the Notify Body.This article focuses on theEU regulatory requirements for the management of the Notify Body.
作者
吕允凤
LV Yun-feng(Center for Medical Device Evaluation.CFDA,Beijing 100044)
出处
《中国医疗器械信息》
2017年第15期1-3,共3页
China Medical Device Information
关键词
欧盟医疗器械法规
公告机构
the regulations on medical devices of the european union
notify body
