The Unique Device Identification (UDI) system, introduced under Article 27 of the MDR, aims to enhance the identification and traceability of medical devices. This document provides comprehensive guidance for assigning and managing Master Unique Device Identification Device Identifiers (Master UDI-DIs) for contact lenses. 


The guidance addresses key aspects such as the structure of Master UDI-DIs, criteria for assignment, and their integration into Eudamed. By ensuring standardized identification, this document helps manufacturers streamline the registration, labeling, and traceability of contact lenses in accordance with EU regulations.


For manufacturers and stakeholders in the contact lens industry, this guidance is highly beneficial as it clarifies the regulatory requirements, timelines, and practical steps for implementing Master UDI-DIs. It also highlights how this system contributes to patient safety and market transparency by enabling efficient tracking of contact lens devices. The document is an essential resource for anyone involved in the production, labeling, or distribution of contact lenses within the EU, providing the knowledge needed to achieve full compliance with regulatory standards.

 

 

Reference:
MDCG 2024-14 - Guidance on the implementation of the Master UDI-DI solution for contact lenses

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