EUDAMED数据库
设立欧洲医疗仪器数据库（EUDAMED）是医疗仪器新规则（法规（EU）2017/745）和体外诊断医疗器械（EU）2017/746）。
EUDAMED将提供在欧盟（EU）提供的医疗器械生命周期的生动画面。它将整合不同的电子系统，整理和处理有关医疗设备和相关公司（如制造商）的信息。在此过程中，EUDAMED旨在提高整体透明度，包括通过公众和医疗保健专业人员更好地获取信息，并加强欧盟不同成员国之间的协调。

EUDAMED将由六个模块组成，分别涉及：演员注册、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、警惕和市场监督。

EUDAMED database

The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746).
EUDAMED will provide a living picture of the lifecycle of medical devices that are made available in the European Union (EU). It will integrate different electronic systems to collate and process information about medical devices and related companies (e.g. manufacturers). In doing so, EUDAMED aims to enhance overall transparency, including through better access to information for the public and healthcare professionals, and to enhance coordination between the different Member States in the EU.
EUDAMED will be 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 market surveillance.

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