Commission Delegated Regulation (EU) 2025/1920 of 12 June 2025 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

In Part C of Annex VI to Regulation (EU) 2017/745 the following sections are added: ‘6.6.2. Spectacle frames, spectacle lenses and ready-to-wear reading spectacles 6.6.2.1. Spectacle frames A UDI-DI shall be assigned to spectacle frames that have the same combination of design parameters, including at least the horizontal boxed lens size (‘‘Master UDI-DI’’). In addition to the requirement laid down in Section 3.9, a new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters referred to in the first paragraph. 6.6.2.2. Spectacle lenses A UDI-DI shall be assigned to spectacle lenses that have the same combination of design parameters, including at least groups of mean sphere (spherical equivalent power), groups of addition power and groups of similar vision impairments (‘‘Master UDI-DI’’). In addition to the requirement laid down in Section 3.9, a new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters referred to in the first paragraph. 6.6.2.3. Ready-to-wear reading spectacles A UDI-DI shall be assigned to ready-to-wear reading spectacles that have the same combination of design parameters, including at least the horizontal boxed lens size and lens spherical power (‘‘Master UDI-DI’’). In addition to the requirement laid down in Section 3.9, a new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters referred to in the first paragraph.’.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 1 November 2028. However, manufacturers may already before that date assign a Master UDI-DI in accordance with Regulation (EU) 2017/745 as amended by this Regulation.