EUDAMED

EUDAMED是欧盟医疗器械数据库(European Database on Medical Devices)，是根据欧盟医疗器械法规(EU)2017/745和体外诊断医疗器械法规(EU)2017/746建立的IT系统。该数据库整合了六个相互关联的模块：经济运营商注册、器械唯一标识(UDI)及器械注册、公告机构和证书、临床调查和性能研究、警戒和上市后监督、市场监管。自2026年5月28日起，前四个模块已强制实施，旨在提高医疗器械透明度，加强欧盟各成员国之间的协调，并实时展示在欧盟上市的医疗器械的生命周期。EUDAMED is the European Database on Medical Devices, an IT system established pursuant to the European Medical Device Regulation (EU) 2017/745 and the Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices. This database integrates six interrelated modules: economic operator registration, unique device identification (UDI) and device registration, notified bodies and their certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market regulation. As of 28 May 2026, the first four modules have been mandated, with the objectives of improving the transparency of medical devices, enhancing coordination among EU member states, and providing real-time insight into the lifecycle of medical devices placed on the EU market.