MDCG guidance addresses Master UDI-DI labeling for contact lenses
Regulatory News | 27 November 2024 |
The European Commission’s Medical Device Coordination Group (MDCG) has issued guidance to assist manufacturers in implementing master unique device identifiers (UDI-DI) for contact lens labeling.
The guidance was prompted by the amendments to the Medical Device Regulations (MDR), which were announced on 20 October 2023. These amendments introduce a new category known as the master UDI-DIs specifically for contact lenses. (RELATED: European Commission sets application date for new approach to contact lens UDIs, Regulatory Focus, 20 October 2023).
Under the current EU device rules, manufacturers have to assign UDIs for all devices except for those that are custom made. Yet officials concluded that the wide variety of types and clinical parameter combinations for certain highly individualized devices means that a “disproportionately high number of identifiers are being assigned, with few regulatory and safety benefits.”
The master UDI-DI is a unique identifier used to group “highly individualised devices” that share the same combination of contact lens design parameters, including the same base curve and diameter, said the guidance. This identifier serves as an “access key to device information related to a group of devices with the same intended purpose and the same principal design, stored in Eudamed.”
The placement of the UDI, including the master UDI-DI on contact lens packaging is dependent on MDR requirements regarding space constraints and sales unit requirements specified in Annex VI Part C 4.2 and 4.3.
For example, the labeling on contact lens blisters “are dependent on space constraints and what is considered the lowest level of packaging that is used by the final user as per the MDR requirements. If contact lens blisters are considered the lowest level of packaging that is used by the final user per the MDR, the Master UDI-DI may be labelled once for a contact lens strip of e.g. 5 units, provided that the manufacturer has carried out the relevant risk management.”
The guidance states that the Master UDI-DI will be assigned to made-to-order (MtO) contact lenses based on the contact lens design parameters specified by the manufacturer.
In addition, the Master UDI-DI may be affixed to a grouping of pack sizes that have the same combination of contact lens design parameters. The UDI would identify all units, pack sizes and higher levels of packaging in that grouping.
The regulation will go into effect on 9 November 2025, but manufacturers can use it earlier.
MDCG guidance on contact lenses
The guidance was prompted by the amendments to the Medical Device Regulations (MDR), which were announced on 20 October 2023. These amendments introduce a new category known as the master UDI-DIs specifically for contact lenses. (RELATED: European Commission sets application date for new approach to contact lens UDIs, Regulatory Focus, 20 October 2023).
Under the current EU device rules, manufacturers have to assign UDIs for all devices except for those that are custom made. Yet officials concluded that the wide variety of types and clinical parameter combinations for certain highly individualized devices means that a “disproportionately high number of identifiers are being assigned, with few regulatory and safety benefits.”
The master UDI-DI is a unique identifier used to group “highly individualised devices” that share the same combination of contact lens design parameters, including the same base curve and diameter, said the guidance. This identifier serves as an “access key to device information related to a group of devices with the same intended purpose and the same principal design, stored in Eudamed.”
The placement of the UDI, including the master UDI-DI on contact lens packaging is dependent on MDR requirements regarding space constraints and sales unit requirements specified in Annex VI Part C 4.2 and 4.3.
For example, the labeling on contact lens blisters “are dependent on space constraints and what is considered the lowest level of packaging that is used by the final user as per the MDR requirements. If contact lens blisters are considered the lowest level of packaging that is used by the final user per the MDR, the Master UDI-DI may be labelled once for a contact lens strip of e.g. 5 units, provided that the manufacturer has carried out the relevant risk management.”
The guidance states that the Master UDI-DI will be assigned to made-to-order (MtO) contact lenses based on the contact lens design parameters specified by the manufacturer.
In addition, the Master UDI-DI may be affixed to a grouping of pack sizes that have the same combination of contact lens design parameters. The UDI would identify all units, pack sizes and higher levels of packaging in that grouping.
The regulation will go into effect on 9 November 2025, but manufacturers can use it earlier.
MDCG guidance on contact lenses
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