The Medical Device Coordination Group (MDCG) just published a new MDCG guidance document on the implementation of the Master UDI-DI solution for contact lenses. MDCG 2024-14 published in November 2024 is the 14th new guidance document endorsed this year.
What is a Master UDI-DI?
The Master UDI-DI is a unique identifier used to group highly individualised medical devices that share specific clinically relevant parameters (e.g., contact lenses with the same base curve and diameter). Specifically, it acts as an access key to device information for a group of devices with the same intended purpose and principal design, as stored in EUDAMED. The assignment of a Master UDI-DI follows EU-designated issuing entity rules and must be linked to a Basic UDI-DI, as defined by the MDR and MDCG 2018-1 guidelines.
Basic UDI-DI (BUDI) and Master UDI-DI (MUDI) assignment differs from the assignment of UDI-DI. Each sub-box shown below would not be assigned UDI-DIs, as this would lead to a too large number of UDI-DIs. The sub-boxes are instead grouped under a Master UDI-DI:
(Source: MDCG 2024-14)
Master-UDI assignment for different contact lenses types
For standard contact lenses, grouped combination of contact lens will correspond to a Master UDI based on their design parameters. Among these parameters, there are at least the ‘Base Curve’ (BC) and ‘Diameter’, together with other relevant parameters as indicated on the labelling for the end-user, the eye care professional, among others. For instance, when a contact lens is available in one material, but in spheric, toric and multifocal design variants, there will be three Basic UDI-DI (per material and design type) and around 9 Master UDI-DIs (for each variant).
Made to order (MtO) contact lenses will have a Master UDI assigned based on combinations of contact lens’ design parameters as defined by the manufacturer, together with other parameters such as base curve and diameter. For instance combination of design parameters for a spherical design include Base Curve + Diameter + Power.
Vigilance reporting
For full compliant MDR contact lenses, the manufacturer should provide the full UDIs (Master UDI-DI + UDI-PI). For legacy contact lenses, the same provisions as for other legacy devices apply. Especially, contact lenses may be identified by EUDAMED ID or UDI-DI together with the UDI-PI for the purpose of vigilance reporting in EUDAMED.
Contact lenses will have to have a Master UDI from 9 November 2025. Manufacturers can comply with this requirement in advance.
Do you have questions on compliance of medical devices in Europe? Contact us here or write an email to mdlaw@obelis.net.
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