Commission Delegated Regulation (EU) 2023/2197 is published in the Official Journal of the European Union. This regulation aims to clarify the assignment of unique device identifiers for contact lenses.
According to this regulation, a UDI-DI shall be assigned to contact lenses that have the same combination of contact lens design parameters. In addition, a new master UDI-DI is required when there is a change in the combination of the design parameters.
The regulation will become legally effective 20 days after its publication in the Official Journal of the European Union and will be applicable on November 9, 2025. Manufacturers are allowed to assign a Master UDI-DI under the existing regulation before the official applicability date.
For further details, please consult the reference.