Article 1
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.’.