New MDCG Guidance document released on the implementation of the Master UDI-DI solution for contact lenses

On November 26th, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the implementation of the Master UDI-DI solution for contact lenses

Since its amendment by Commission Delegated Regulation (EU) 2023/2197 in July 2023, Regulation (EU) 2017/745 (MDR) foresees the assignment of a Master UDI-DI for contact lenses, which are highly individualised devices. MDCG 2024-14 now provides guidance for manufacturers in the implementation of Master UDI-DI rules for contact lenses as regards its structure, assignment, labelling and registration in EUDAMED.

MDCG 2024-14: Guidance on the implementation of the Master UDI-DI solution for contact lenses.

Some key takeaways from MDCG 2024-14

Commission Delegated Regulation (EU) 2023/2197 amended the MDR to foresee the assignment of a Master UDI-DI (MUDI) for contact lenses, with a differentiation between mass-produced ‘standard contact lenses’ and ‘made to order contact lenses’ which are based on a specific individual order.

MUDI assignment to standard and made to order contact lenses: For standard contact lenses, MUDI’s under a given Basic UDI-DI (BUDI) will be assigned to a given combination of contact lens design parameter values, including at least the ‘Base Curve’, ‘Diameter’, and other relevant parameters. For made to order contact lenses, the MUDI will also be assigned based on a combination of contact lens design parameters and other relevant parameters, but the actual parameter values do not need to be included.

MUDI assignment on packaging: The MUDI may be associated to a grouping that have the same combination of design parameters, which would include identification of all units of use, pack sizes and higher levels of packaging in that grouping. Higher levels of packaging, if applicable, must have their own MUDI since the MUDI replaces the UDI-DI for contact lenses.

Vigilance: In case of vigilance reporting on contact lenses that are fully MDR compliant, the manufacturer should provide the full UDI (Master UDI-DI + UDI-PI) in, for example, the Manufacturer Incident Report (MIR) form. For legacy contact lenses, the same principles as for other legacy devices apply.

Timeline for application: The assignment of Master UDI-DI to contact lenses becomes mandatory from November 9th, 2025. Manufacturers can choose to comply in advance, pending the technical solution thereto is available.

Registration in EUDAMED: the MUDI will be registered and used in EUDAMED instead of the UDI-DI by selecting the applicable special device type.

What does it mean to you?

MDCG 2024-14 is important for all manufacturers of contact lenses, as well as other economic operators that are involved in placing such medical devices on the market. However, even though all economic operators must contribute to an appropriate level of traceability, the main responsibility for achieving proper device identification and traceability lies with the manufacturer.