MDCG 2025-7 Clarifies Master UDI-DI Timelines for Optical Devices

On 10 July 2025, the Medical Device Coordination Group (MDCG) published Position Paper MDCG 2025-7, clarifying the requirements and timelines for implementing the 'Master UDI-DI' for optical devices such as contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles.

These products are considered Class I low-risk medical devices under the Medical Device Regulation (MDR) and must comply with specific deadlines. Due to their high level of individualization, a specific assignment solution called “Master UDI-DI” has been developed. It serves as the identifier for a group of devices with defined design-relevant similarities, aiming to reduce the number of UDI-DIs that must be reported in the UDI database (EUDAMED).

UDI Labelling Requirements Overview:

• According to Article 123(3)(f) of the MDR, UDI labelling for Class I devices, including spectacle frames, lenses, and reading glasses, applies from 26 May 2025.

• As stated in Regulation (EU) 2024/1860, the UDI/device registration module becomes mandatory from Q1 2026 (six months after publication in the OJEU).

• Under 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 including the Master UDI-DI on the label.

Implementation Deadlines:

• Contact lenses: Master UDI-DI mandatory from 9 November 2026

• Spectacle frames, lenses, and ready-to-wear reading spectacles: Master UDI-DI mandatory from September 2028

Manufacturers may implement the Master UDI-DI earlier. If so, it must appear on the label and be registered in EUDAMED. Once the vigilance and post-market surveillance module becomes mandatory (expected Q3 2026), the assigned Master UDI-DI must be used in incident reporting, even if the final implementation deadline has not yet passed.

For full details, read the official MDCG 2025-7 Position Paper on the European Commission website.

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