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 spectacle frames, spectacle lenses and ready-to-wear reading spectacles
G/TBT/N/EU/1110
Date of arrival:
2025 March 04
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Final date for comments:
2025 May 03
Description
The proposed Regulation is a Delegated measure adopted pursuant to Article 27(10)(b) of Regulation (EU) 2017/745 on medical devices, whereby the Commission is empowered to amend Annex VI to that Regulation in light of international developments and technical progress in the field of Unique Device Identification (UDI). In order to resolve the implementation issue concerning the registration of UDI device identifiers (“UDI-DI”) data elements in the European database on medical devices (“Eudamed”) for highly individualised devices, and in particular spectacle frames, spectacle lenses and ready-to-wear reading spectacles, 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.
Disclaimer:
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