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MDCG 2024-14 – rev.1 – Guidance on the implementation of the Master UDI-DI solution for contact lenses (August 2025)

The introduction of the Unique Device Identification (UDI) system referred to in Article 27 of Regulation (EU) 2017/745 on medical devices (MDR)1 aims to ensure an adequate level of identification and traceability with respect to medical devices. For contact lenses, which are devices presenting a high level of individualisation, the assignment of a Master UDI-DI has been foreseen according to EU Regulation.

This document aims to provide guidance in the implementation of Master UDI-DI rules for contact lenses as regards its structure, assignment, labelling and registration in Eudamed.

Read the news announcement published by European Health and Digital Executive Agency on 26 August 2025.


OpenEdition vous propose de citer ce billet de la manière suivante :
lsgilbert (8 septembre 2025). MDCG 2024-14 – rev.1 – Guidance on the implementation of the Master UDI-DI solution for contact lenses (August 2025). ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/14lyu


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