通报号：G/TBT/N/EU/963    

中文标题：

委员会授权条例草案，修订欧洲议会和理事会关于隐形眼镜唯一设备标识符分配的第2017/745号条例（欧盟）；

英文标题：

Draft Commission Delegated Regulation amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses;

成员国：欧盟

通报日期：2023-03-30

内容概述：

The proposed Regulation is a Delegated measure adopted pursuant to Article 27 (10) (b) of Regulation (EU) 2017/745 whereby the Commission is empowered to amend Annex VI of that Regulation in light of international developments and technical progress in the field of Unique Device Identification. In order to resolve the implementation issue concerning the registration of UDI-DI data elements in Eudamed for highly individualised devices, and in particular contact lenses, the Commission is empowered to establish a specific UDI-DI assignment rule for such devices. This solution will allow a more effective implementation of the UDI system at European level.