The European Commission assigns a Unique Device Identifier for contact lenses
On 10 July 2023, the European Commission adopted Regulation (EU) 2023/2197 that modifies Part C of Annex VI to Regulation (EU) 2017/7405 on medical devices by setting new requirements that will equally apply to both (i) standard contact lenses and (ii) made to order contact lenses. These requirements will obligatorily apply as from 9 November 2025, although economic operators can apply the new rules on a voluntary basis prior to that date. According to these new rules, economic operators will have to assign a device identifier (UDI-DI) and a production identifier (UDI-PI) to those lenses that have the same combination of contact lens design parameters, including at least base curve and diameter (“Master UDI-DI”). Accordingly, economic operators will need to adapt technologies for printing and scanning UDI-DI that will be affixed on the packaging of each contact lens they produce in order to help track contact lenses throughout the supply chain.
