MDCG 2025–7 Revision 1 from the Medical Device Coordination Group (MDCG) clarifies the timeline for implementing the “Master UDI-DI” system for certain medical devices such as contact lenses, eyeglass frames, eyeglass lenses, and ready-made reading glasses.
Master UDI-DI for contact lenses and eyeglasses
The revised MDCG Guidance Document focuses on the timelines for two main product categories:
- Contact lenses (Class IIa/IIb products)
- Spectacle frames, spectacle lenses, and ready-made reading glasses (Class I products)
The purpose of the Master UDI-DI is to simplify the identification and registration of groups of similar, highly customized products in the European database Eudamed.
The next milestones: 2026 to 2028
The implementation of the Master UDI-DI is divided into several phases spanning several years. The following table summarizes the most important deadlines for manufacturers:
| Regulatory requirement | Affected products | Deadline (date of entry into force) |
|---|---|---|
| UDI labeling requirement | Contact lenses (Class IIa/IIb) | May 26, 2023 |
| UDI labeling requirement | Spectacle frames, spectacle lenses & ready-made spectacles (Class I) | May 26, 2025 |
| Mandatory registration in the Eudamed UDI/Device module | All products mentioned | May 28, 2026 |
| Implementation of the Master UDI-DI | Contact lenses | November 9, 2026 |
| Implementation of Master UDI-DI | Eyeglass frames, eyeglass lenses & ready-made reading glasses | November 1, 2028 |
Please note: The Eudamed requirement comes before the Master UDI-DI requirement. This creates a regulatory “time gap” that many manufacturers are currently underestimating.
The critical time gap: Registration without Master UDI-DI
From May 2026, all affected products must be registered in the Eudamed UDI/Device module – even if the Master UDI-DI is not yet mandatory for these products.
The consequence:
- Contact lenses: approx. 5‑month transition period
- Glasses & lenses: approx. 29-month transition period
During this time, manufacturers must work with transitional identifiers (e.g., existing UDIs or internal product identifiers). Without a clear system, there is a risk of inconsistent data records in Eudamed, subsequent changes under time pressure, and increased audit and vigilance risks.
Why the voluntary Master UDI-DI makes strategic sense
The MDCG expressly recommends the voluntary early introduction of the Master UDI-DI. Those who take this step will immediately activate the labeling and registration requirements, but will avoid the dual logic of the transition phase and create clear, scalable processes from the outset.
This will become particularly relevant with the Eudamed vigilance module (planned for Q2 2027 at the latest): Every Master UDI-DI that has already been assigned – even voluntarily – must then be used for vigilance reports, regardless of the official mandatory date.
Our consulting services: Support for your Eudamed strategy
The correct assignment of the Master UDI-DI and the maintenance of the Eudamed database are not purely administrative tasks but are crucial for your marketability. reuschlaw supports you with:
- Timely registration and data maintenance in Eudamed.
- The legally compliant implementation of the Master UDI-DI in your processes.
- Reviewing your labeling and vigilance workflows.
Do you have questions about the specific deadlines for your product portfolio? Contact us for targeted compliance advice.
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