Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses

In Part C of Annex VI to Regulation (EU) 2017/745 the following sections are added: ‘6.6. Highly individualised devices 6.6.1. Contact lenses 6.6.1.1. Standard contact lenses A UDI-DI shall be assigned to standard contact lenses that have the same combination of contact lens design parameters, including at least base curve and diameter (“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. 6.6.1.2. Made to order contact lenses A UDI-DI shall be assigned to made to order contact lenses that have the same combination of contact lens design parameters, including at least base curve and diameter (“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 9 November 2025. However, manufacturers may already before that date assign a Master UDI-DI in accordance with Regulation (EU) 2017/745 as amended by this Regulation.