Article 1
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.’