When is the Master UDI-DI mandatory for contact lenses and spectacle frames?
The Master UDI-DI will become mandatory for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles from September 2028, and for contact lenses from 9 November 2026. These deadlines are defined in MDCG 2025-7 and the relevant Delegated Regulations.
Master UDI-DI requirements under the MDR
The Medical Device Coordination Group (MDCG) published MDCG 2025-7 to clarify the timelines for implementing the Master UDI-DI for optical devices such as contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. All these products are considered class I medical devices under the MDR and must comply with specific deadlines.
Read the full document here:
MDCG 2025-7 – Timelines of the implementation of Master UDI-DI
UDI labelling requirements
According to Article 123(3)(f) of the MDR, the UDI labelling requirements apply as follows:
- From 26 May 2023 for class IIa and IIb devices
- From 26 May 2025 for class I devices, including spectacle frames, lenses, and reading glasses
EUDAMED registration module
According to Regulation (EU) 2024/1860 and the latest EUDAMED timeline, the UDI/device registration module will become mandatory from the first quarter of 2026. This is expected to happen six months after the European Commission publishes the notice confirming the module’s full functionality in the Official Journal of the European Union.
Master UDI-DI for contact lenses
Based on Commission Delegated Regulation (EU) 2023/2197, the Master UDI-DI becomes mandatory for contact lenses from 9 November 2026. Products placed on the market before this date are exempt from the obligation to include the Master UDI-DI on the label.
Master UDI-DI for spectacle frames, lenses, and reading glasses
The Delegated Regulation of 12 June 2025 establishes that the Master UDI-DI must be implemented for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles by September 2028.
Voluntary implementation before the deadline
Manufacturers can choose to implement the Master UDI-DI before the mandatory deadline. In such cases, the identifier must appear on the label and be registered in EUDAMED. Voluntary implementation is encouraged to streamline processes and prepare for upcoming regulatory obligations.
Use of Master UDI-DI in vigilance and PMS
When the vigilance and post-market surveillance module of EUDAMED becomes mandatory (expected Q3 2026), the assigned Master UDI-DI must be used in incident reporting, even if the full implementation deadline has not yet passed. This requirement applies to both contact lenses and spectacle devices.
Key deadlines
UDI labelling
Class IIa and IIb devices: from 26 May 2023
Class I devices (including spectacle frames, lenses, and reading glasses): from 26 May 2025;
EUDAMED device registration
Expected from Q1 2026, six months after publication of functionality notice in the Official Journal of the European Union;
Master UDI-DI for contact lenses
Mandatory from 9 November 2026
Not required for products placed on the market before this date;
Master UDI-DI for spectacle frames, lenses, and reading glasses
Mandatory from September 2028.
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