Master UDI-DI Solution for Contact Lenses Guidance

Today the Medical Device Coordination Group (MDCG) has released the MDCG 2024-14 guidance document, which provides essential information on the implementation of the Master Unique Device Identifier (UDI-DI) solution for contact lenses. This guidance is crucial for manufacturers, distributors, and eye care professionals involved in the production and distribution of contact lenses.

The Master UDI-DI is a unique identifier used to group highly individualized devices, such as contact lenses, which present specific similarities in their design parameters. This system aims to enhance the traceability and identification of medical devices, ensuring compliance with the European Union’s Medical Device Regulation (MDR).

Highlights of the MDCG 2024-14 Guidance Document for Contact Lenses:

• • Assignment of Master UDI-DI: The guidance outlines the process for assigning Master UDI-DI to both standard and made-to-order (MtO) contact lenses. For standard lenses, the Master UDI-DI is based on a combination of design parameters like base curve and diameter. For MtO lenses, it includes additional parameters such as power, cylinder, and axis.
  • Labeling Requirements: The document provides examples of how the Master UDI-DI should be labeled on contact lens packaging. This includes both Automatic Identification Data Capture (AIDC) and Human Readable Interpretation (HRI) carriers. Clear labeling examples based on the GS1 issuing entity are included.
  • Master UDI-DI Assignment on Container Package, Packaging Levels, and Packaging Variants: The Master UDI-DI may be associated with a grouping regardless of pack size that have the same combination of contact lens design parameters. Higher levels of packaging shall have their own Master UDI-DI if applicable. If within the same package there are contact lenses with different Master UDI-DIs, then the package should be considered as a transport container that should not have an assigned Master UDI-DI.
  • Vigilance Reporting: Manufacturers are required to provide the full UDI (Master UDI-DI + UDI-PI) in case of vigilance reporting for contact lenses. This ensures that any incidents can be traced back to the specific device involved.
  • Timeline for Implementation: The regulation on Master UDI-DI for contact lenses will become mandatory from November 9, 2025. Manufacturers are encouraged to comply in advance to ensure a smooth transition.

This new Guidance document provides a clear explanation of the Master UDI-DI system to be applied for contact lenses in an effort to enable the traceability of contact lenses in the post-market phase. By following the guidelines set out in the MDCG 2024-14 document, manufacturers can ensure they meet regulatory requirements.

For more detailed information, please find the full MDCG 2024-14 “Guidance on the implementation of the Master UDI-DI solution for contact lenses“ here.

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Implementing the Master UDI-DI system ensures compliance and enhances patient safety. Prepare now for the November 9, 2025, deadline. Contact us for assistance with navigating these new requirements.

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• • • EU Authorized Representative
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