European regulations require a unique identification system for medical devices (UDI) to improve and facilitate traceability. After launching a major consultation process last spring, the European Commission has just approved the creation of a Master UDI-DI for certain so-called “highly individualized” medical devices.
The medical devices, such as contact lenses, which were included in the consultation, can present a high level of granularity due to the numerous combinations of possible clinical parameters. As a result, contact lenses may require a large number of UDI-DIs and therefore proportionally multiple entries on Eudamed. Thus, to avoid individual registrations for each device, and to enable manufacturers to fulfill their obligation to apply a UDI and then register these devices in the EUDAMED database, it will be possible to assign a Master UDI-DI to eligible products and submit only one EUDAMED registration. However, be careful not to confuse the Master UDI-DI with the BASIC UDI. The latter is still required for all MDR CE-stamped DM. It is up to manufacturers to identify “highly individualized” DMs eligible for Master UDI-DI.
For the moment, the decision concerns only standard contact lenses and custom-made contact lenses with identical design parameters, at least in terms of diameter and base curve. However, the text provides for the possibility of extending the notion of “highly individualized device” to other products with the same type of granularity.