The latest guidance from the Medical Device Coordination Group (MDCG), published as MDCG 2025-7, introduces the implementation of Master Unique Device Identification - Device Identifiers (UDI-DIs) for a number of highly individualised devices.
The use of a Master UDI-DI aims to strengthen and enhance the traceability and recording of UDIs. Master UDI-Ds allow the grouping of highly individualised devices with specific design similarities under a common identifier to be assigned and registered on Eudamed. This should effectively eliminate the need for a manufacturer to have dozens if not hundreds of UDI-DIs for very similar devices by unifying them under one Master UDI-DI.
Devices Addressed by MDCG 2025-7
The devices covered by this guidance are:
- Contact lenses
- Spectacle frames
- Spectacle lenses
- Reading spectacles
According to MDCG 2021-24:
- Corrective contact lenses are classified as Class IIa (short-term use) or Class IIb (long-term use) medical devices.
- Spectacle frames, spectacle lenses, and reading spectacles are classified as Class I medical devices.
Implementation Deadlines
MDCG 2025-7 aims to clarify the timelines of implementation of Master UDI-DIs for these devices, as well as the obligations of manufacturers relating to Eudamed and vigilance reporting.
Key dates include:
- Manufacturers must place UDI carriers on the label of a device and on all higher levels of packaging for Class I devices from 26 May 2025
- Manufacturers must use the UDI/Device registration module in Eudamed by Q1 2026
- Master UDI-DIs become mandatory for contact lenses from 9 November 2026
- Master UDI-Dis become mandatory for spectacle lenses and reading glasses from September 2028
- If a manufacturer has assigned a Master UDI-DI to a device before Q1 2026, they must use it for vigilance reporting.
Moving Forward with Master UDI-DIs
The introduction of Master UDI-DIs marks a step forward in improving the traceability and administrative workload of highly individualised medical devices. By allowing manufacturers to group similar products under a single identifier, the guidance aims to reduce burden while maintaining safety and compliance standards. Manufacturers of these devices should take note of the implementation timelines and obligations, particularly around Eudamed registration and vigilance reporting, to ensure that they can prepare effectively for full compliance.
