New Guidance Timelines for Master UDI-DI Implementation

The Medical Device Coordination Group (MDCG) has published Position Paper MDCG 2025-7, clarifying the timelines for the implementation of Master UDI-DIs for contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles.

Key Takeaways

• The Master UDI-DI is a solution to reduce identifier overload for highly individualized devices by grouping them based on core design and performance parameters.
• This is relevant for devices where assigning a UDI-DI per configuration would be excessive (e.g., spectacle frames, contact lenses).

Voluntary Early Use Encouraged

Manufacturers for which Master UDI-DIs are applicable are urged to voluntarily assign and register Master UDI-DIs before the mandatory deadlines to benefit from enhanced traceability and streamlined vigilance reporting—especially relevant when the vigilance and PMS modules of EUDAMED become mandatory (expected Q3 2026).

Implications

• Early implementation of Master UDI-DIs supports smooth integration with the EUDAMED ecosystem.
• Required for proper vigilance case reporting once EUDAMED modules are fully operational.

For full details, see the MDCG 2025-7 Guidance and related documents MDCG 2024-14 or the EU Commission page on this topic Unique Device Identifier – UDI – European Commission.

How MedEnvoy Can Help You

MedEnvoy offers expert regulatory support to manufacturers in navigating UDI-DI requirements and compliance such as:

• Assigning Master UDI-DIs based on device grouping rules
• Ensuring labeling meets UDI standards
• Registering devices correctly in EUDAMED

If you have any questions regarding the above, we encourage you to reach out to our regulatory experts here.