Medical devices with a high degree of customization, such as contact lenses, are now subject to a new EU regulation aimed at simplifying and streamlining product identification within the framework of the Medical Device Regulation (MDR). The regulation introduces a new type of product identifier, the Master UDI-DI, which must be applied to contact lenses starting from November 9, 2025.
What is a Master UDI-DI and why is it needed?
Contact lenses are available in a wide range of variants and configurations, with many parameters that vary in value. Assigning a unique UDI-DI to each configuration, in line with standard requirements, would result in an unreasonably high number of registrations—potentially complicating traceability rather than enhancing it.
To address this, the Master UDI-DI is being introduced—an identifier that sits between the Basic UDI-DI and individual UDI-DIs. It is used during registration in EUDAMED and is combined with the UDI-PI to generate each product’s complete UDI. This allows for a more manageable registration process without compromising traceability or patient safety.
What applies today and what lies ahead?
Currently, contact lenses are included, with a provisional implementation date of 9 November 2025 (subject to revision). At the same time, extensive work is underway within the EU to develop guidance and regulations to also include spectacle frames, prescription lenses, and ready-made reading glasses. This work is expected to be completed within approximately one year.
Products within these categories that fall under the MDR will not be able to be registered in EUDAMED without an assigned Master UDI-DI.
What does this mean for you as a manufacturer?
- If you use AIDC scanning in your process, ensure that your system can read the new information, including the Master UDI-DI.
- Contact your software provider to ensure that your system is updated and compatible.
- Please note that during a transition period, products with and without a Master UDI-DI will coexist on the market. Therefore, your system needs to be able to handle both variants.
What changes can be expected on the labels?
- Do you already use AIDC (e.g., GS1 DataMatrix)?
Then the Master UDI-DI will be added to the existing code.
- Do you not use AIDC?
Then you need to add a GS1 DataMatrix containing all UDI information, including the Master UDI-DI.
- The labeling must also include human-readable information (HRI).
Two new application identifiers
GS1 has introduced two new application identifiers as part of the Master UDI-DI requirement, which are as follows:
- AI (8014) for standard lenses
AI (03) for made-to-order lenses (MtO – Made to Order)
This means that although the information in the 2D code is essentially the same, the new Master UDI-DI will be encoded within it.
Example of labeling with Master UDI-DI
The label includes:
- GTIN (01): Global Trade Item Number
- Manufacture and expiry dates (11) & (17)
- Batch or serial number (10)
- Master UDI-DI (8014): Identifies the contact lens group
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