本文详细解释了欧盟医疗数据库EUDAMED的定义、目的、模块、角色和操作,以及与其他医疗设备相关的法规和系统的关系。EUDAMED是一个IT系统,用于实施欧盟医疗器械法规和体外诊断医疗器械法规,旨在增强医疗设备领域的透明度和监管效率。
EUDAMED is the EU's database for medical devices and in vitro diagnostics, established by two regulations. It consists of six …
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and …
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