欧盟、德国及中国医疗器械法规
欧盟、德国及中国医疗器械法规简要介绍简要介绍简要介绍简要介绍简要介绍
EU UDI 服各台 信息汇总
Regulation (EU) 2017/745 on medical devicesEN••• and Regulation (EU) 2017/746 on in vitro diagnostic medical devicesEN••• introduce an EU device identification system based on a unique device identifier (UDI) allowing easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Manufacturers can already enter UDI/Device information in the system on a voluntary basis.
2023.03.15欧盟理事会法规(EU)2017/745 MDR修正案 2023/607 以及关于MDD的CE证书延期的FAQ
与公告机构签订MDR书面审核合同，并且须在规定时间前签订（旧证书有效期内最迟于2024年9月26日前）才能适用延长的过渡期。2023/607 以及关于MDD的CE证书延期的FAQ
