EU Postpones Master-UDI Assignment Deadline for Contact Lens Makers

In July 2023, the European Commission (EC) adopted Commission Delegated Regulation 2023/2197 on the assignment of UDIs for contact lenses. This regulation implemented special rules for the UDI-DI assignment to contact lenses and also gave manufacturers additional time to implement these special UDI requirements. 

This regulation is now amended by Commission Delegated Regulation 2025/788. Under Regulation 2023/2197, contact lens manufacturers had until  November 9, 2025, to assign a “Master UDI-DI” to contact lenses. Regulation 2025/788 amends this date to November 9, 2026.

Exceptions to the UDI-DI assignment for contact lenses

Those wondering what a “Master UDI-DI” is, the EC made an exception to the way UDI-DIs must be assigned to contact lenses, as these are highly individualized medical devices. A “Master-UDI-DI” solution was adopted for contact lens manufacturers. 

Contact lens varieties depend on patient needs. If each of these variants were assigned a UDI-DI, this would result in “a proliferation of UDI-DIs” for similar contact lenses.  And, according to the EC, the overwhelm of EUDAMED—the European Database on Medical Devices—is disproportionate compared to the safety risk associated with contact lenses. 

As such, contact lens manufacturers can assign a “Master-UDI-DI” to lenses with the same combination of contact lens design parameters, including at least the base curve and diameter. 

Amendments to the MDR Annex VI

Annex VI, section C, MDR was revised by including these exceptions in section 6.6: 

6.6 Highly individualized 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 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 the base curve and diameter (“Master UDI-DI”).

In addition to the requirement in Section 3.9, a new Master UDI-DI is required.

Implement UDI changes now

With the adoption of the amended date of application, the Commission acknowledged that UDI change implementation in internal systems is complex and time-consuming. We recommend implementing these changes promptly. We can assist manufacturers with their UDI system implementation and EUDAMED device registration.