EU Unveils UDI System for Contact Lenses

The European Commission has recently issued Delegated Regulation 2023/2197 which outlines the assignment of unique device identifiers (UDIs) for contact lenses, with the slated implementation date set for 9 November 2025.

Contact lenses are considered as “highly individualized devices” which would force their manufacturers to register a disproportionate amount of UDIs for the same product. Therefore, based on experience gained from establishing the UDI system and from other jurisdictions, an initiative was started to group highly individualized devices with clear clinical similarities under an identified referred to as the “Master UDI”.

Whilst this Delegated Regulation is specific to contact lenses, you can expect this to be extended to other highly individualized devices.

So how will contact lens manufacturers go about assigning UDI?

A Master UDI-DI (can we call it MUDI?) will be assigned to identify a group of contact lenses. That means that lenses with the “same combination of contact lens design parameters, including at least base curve and diameter” shall be assigned the same MUDI. If there is a change in the combination of these characteristics, a new MUDI would be required. A similar approach is to be followed for made-to-order contact lenses.