EUDAMED - European Database on Medical Devices

EUDAMED - 欧盟医疗器械数据库

EUDAMED is the IT system established by Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices.EUDAMED是根据医疗器械法规（EU） 2017/745和体外诊断医疗器械法规（EU） 2017/746建立的IT系统。

EUDAMED provides a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It integrates different electronic systems to collate and process information about medical devices. EUDAMED aims to enhance overall transparency, including better access to information for public and healthcare professionals, and to enhance coordination between the different Member States in the EU.EUDAMED提供了欧洲联盟（EU）的医疗器械生命周期的生动画面。它集成了不同的电子系统来整理和处理有关医疗设备的信息。EUDAMED旨在提高整体透明度，包括为公众和医疗保健专业人员提供更好的信息获取途径，并加强欧盟不同成员国之间的协调。

EUDAMED is composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance and market surveillance.

EUDAMED由六个模块组成，涉及：参与者注册、唯一器械标识（UDI）和器械注册、公告机构和证书、临床调查和性能研究、警惕和上市后监督以及市场监督。

Starting from May 28, 2026, the use of the first four modules is mandatory:从2026年5月28日开始，前四个模块的使用是强制性的：

Actor registration,UDI/Devices registration,Notified Bodies and Certificates,Market Surveillance.运营方注册，UDI/器械注册，公告机构和证书，市场监督。

Sign in to EUDAMED登录 EUDAMED 系统

Access to EUDAMED is restricted to users identified by their EU Login account.访问EUDAMED仅限于通过其EU登录帐户识别的用户。

You already have an EU Login account您已经有一个欧盟登录帐户

https://webgate.ec.europa.eu/eudamed/secure

No EU Login account无欧盟登入帐户? Create your EU Login account创建您的EU登录帐户

Warning 提醒2025-11-27

The notice declaring the functionality of the first four modules has been published in the OJEU. This publication initiates a 6-month transition period. Therefore, starting from May 28, 2026, it will be mandatory to use the first four modules: Actor, UDI/devices, NBs & Certificates, and Market Surveillance

关于前四个模块功能的通知已在《欧盟官方公报》上发布。此次发布启动了为期六个月的过渡期。因此，自 2026 年 5 月 28 日起，必须使用前四个模块：参与者、UDI/器械、公告机构与证书以及市场监督。