The European Medical Devices Regulation (MDR) requires that each distinct model of a medical device has its own unique Unique Device Identifier – Device Identifier (UDI-DI). For contact lenses, given their vast variety, this would entail manufacturers assigning a multitude of UDI-DIs. In response to concerns raised by stakeholders, the European Commission (EC) has introduced exceptions to the UDI-DI assignment for contact lenses.
The EC has published a new delegated regulation that amends Annex VI, Part C of the MDR. This regulation, named “Commission Delegated Regulation (EU) 2023/2197,” acknowledges the unique nature of contact lenses regarding UDI-DI assignment. The EC was wary that requiring a separate UDI-DI for each contact lens variation would inundate the European Databank on Medical Devices (EUDAMED) with device registrations, leading to administrative challenges. To address this, the EC opted to modify the regulations.
The newly adopted provisions pertain to “Highly individualized devices,” which encompass contact lenses. It specifies that for “standard contact lenses,” a single “Master UDI-DI” should be assigned to those with the same design parameters, such as base curve and diameter. When there is a change in these parameters, a new Master UDI-DI must be generated.
Similarly, for “made-to-order contact lenses,” the regulation states that they should have a specific “Master UDI-DI” for contact lenses with the same design parameters. Any alteration in these parameters will necessitate a new Master UDI-DI.
This revision, effective from November 9, 2025, is beneficial for contact lens manufacturers. Although this change only pertains to contact lenses, the EC is open to reconsidering the legislation for other “highly individualized devices” that may warrant exceptions from individual UDI-DI requirements. The move underscores the EC’s willingness to adapt regulations to specific medical device categories where appropriate.
This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.
