Regulation (EU) 2023/2197 on Master UDI-DI for Contact Lenses: Now Mandatory

Commission Delegated Regulation (EU) 2023/2197 entered into force on 9 November 2023, followed by a three-year transition period. Therefore, the use of Master UDI-DI for contact lenses becomes mandatory starting today.

In the meantime, manufacturers may voluntarily choose to assign a Master UDI-DI for their contact lenses, prior to the mandatory application date.

Background on Master UDI-DI

The purpose of the Master UDI-DI (MUDI-DI) is to group together product variants that share the same intended purpose, risk class, and essential design/manufacturing characteristics, in order to structure EUDAMED registrations more efficiently. Certain device types, such as contact lenses, may require a large number of individual UDI-DIs due to minor variations (e.g., prescription strength), which would result in a high volume of EUDAMED entries. While each variant still requires a UDI-DI, the MUDI-DI allows manufacturers to link these products under a single EUDAMED registration, facilitating compliance while maintaining traceability.

Manufacturers may refer to guidance document MDCG 2024-14 for more information (‘Guidance on the implementation of the Master UDI-DI solution for contact lenses’).