European Commission sets application date for new approach to contact lens UDIs
The European Commission has published a delegated regulation on assigning unique device identifiers (UDIs) to contact lenses and set the application date as 9 November 2025.Under the terms of new EU device and diagnostic regulations, manufacturers need to assign UDIs to all products except custom-made devices. However, as EU authorities gained experience from setting up and implementing the UDI system and learned from what has happened in other regions, they concluded that “highly individualized devices” face a “disproportionate level of granularity.”
That conclusion led the EU to outline plans to adopt a different system for highly individualized devices, starting with contact lenses. The Commission sought feedback on its plans earlier this year and released details of the application of the new model to contact lenses in July.
Now, the Commission has published the delegated regulation on contact lenses in the Official Journal of the European Union. The final document is almost identical to the version that the Commission shared in July. The key change is that there is now an application date for the delegated regulation, 9 November 2025. The Commission has also changed a footnote and removed background information on the policy.
The details of how the Commission intends to resolve the UDI implementation issue and try to free manufacturers of contact lenses from disproportionate reporting requirements are unchanged. Rather than give a UDI to each device, manufacturers will use a “Master UDI-DI” to identify a group of contact lenses. The approach could be extended to other highly individualized devices in the future.
There is an overlap between the Commission’s solution for contact lenses and an existing provision of the Medical Device Regulation (MDR) that applies to system and procedure packs, configurable devices and software. MDR already includes the concept of UDI-DI grouping of several devices for those products but lacks a similar approach for highly individualized devices.
The plan for contact lenses could be controversial. Medtech trade groups and companies pushed back against the draft proposals earlier this year, with Johnson & Johnson warning that “the Master UDI-DI may compromise patient safety by reducing the ability to find accurate information about the specific device, making adverse event reporting more complicated, less detailed and impacting efficient and targeted field safety corrective actions.”
EU officials made some changes in response to the 26 pieces of feedback they received, primarily by removing a requirement for clinical sizes to be included as additional production identifiers of contact lenses but retaining the core concept of using a Master UDI-DI.
Delegated Regulation
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