MDCG outlines timeline for complying with new UDI-DI for contact lenses and glasses

The European Commission’s Medical Device Coordination Group (MDCG) has published a position paper clarifying the timelines for manufacturers to comply with master unique device identifiers (UDI-DI) for contact lenses, spectacle frames, and reading glasses.

The paper was prompted by the amendments to the Medical Device Regulations (MDR), which were announced on 20 October 2023. These amendments introduced a new category known as the master UDI-DIs for highly individualized medical devices such as contact lenses, spectacle frames and reading glasses. (RELATED: European Commission sets application date for new approach to contact lens UDIs, Regulatory Focus 20 October 2023)

The paper states that “the Master UDI-DI technical solution aims to group highly individualised devices with specific similarities in terms of relevant design parameters under a common identifier to be assigned and registered in the UDI/Device registration module of Eudamed, thus relieving manufacturers, distributors and the Eudamed database from having too many identifiers assigned for similar devices. The Master UDI-DI technical solution for such devices is being developed by the EU UDI issuing entities.”

Corrective contact lenses are considered class IIa (short-term use) or class IIb (long-term use) medical devices. Spectacle frames (i.e. glasses), spectacle lenses and ready-to-wear reading spectacles are considered class I medical devices.

The paper specifies that the key dates are the following:

UDI on labelling of Class I devices went into effect on 26 May 2025;
Mandatory UDI registration in EUDAMED is the first quarter of 2026;
Mandatory implementation of Master UDI-DI for contact lenses is 9 November 2026; while for frames and reading glasses is September 2028. Contact lenses produced before 9 November 2026 are not required to have a Master UDI-DI on the label.

The paper states that “manufacturers of contact lenses, spectacle frames, spectacle lenses and ready-to-wear reading spectacles are strongly encouraged to make use of the voluntary assignment of Master UDI-DI before the mandatory dates of application in due time, to be able to take advantage of the features offered by the Master UDI-DI solution.”

MDCG issued a guideline on how to comply with the UDI-DI for contact lenses last November 2024. (RELATED: MDCG guidance addresses Master UDI-DI labeling for contact lenses, Regulatory Focus 27 November 2024)

MDCG position paper

MDCG outlines timeline for complying with new UDI-DI for contact lenses and glasses

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