In July 2023, the European Commission introduced Commission Delegated Regulation 2023/2197, establishing specific rules for assigning Unique Device Identifiers (UDI) to contact lenses. This regulation not only outlined tailored requirements for UDI-DI assignment but also provided manufacturers with an extended timeline to comply.
Commission Delegated Regulation 2025/788 has now updated these provisions. While the original deadline for assigning a “Master UDI-DI” was set for November 9, 2025, the new regulation extends this deadline by one year, to November 9, 2026.
The delegating regulation can be accessed using the following link
