The MDCG guidance document 2024-14 has recently been updated to reflect regulatory changes. This document provides clarification on the application of the Master UDI-DI for contact lenses under the EU Medical Devices Regulation (MDR).
To offer some background to this document, the Unique Device Identification (UDI) system, as outlined in Article 27 of Regulation (EU) 2017/745 (MDR), is designed to improve the identification and traceability of medical devices. Manufacturers must assign the following identifiers—Basic UDI-DI, UDI-DI, and UDI-PI—to all devices (except custom-made ones) before placing them on the market. These identifiers must comply with the rules set by designated issuing entities. To enhance traceability, manufacturers are also required to register Basic UDI-DIs and UDI-DIs in EUDAMED, the European database for medical devices.
Contact lenses are classified as highly individualised devices. For these, the MDR (Annex VI, Part C, Section 6.6.1) allows the use of a Master UDI-DI. This was introduced by Commission Delegated Regulation (EU) 2023/2197 and later amended by Regulation (EU) 2025/788, which updated the date of application.
While all economic operators have a role in ensuring device traceability (Article 25 MDR), the primary responsibility lies with the manufacturer to implement and maintain effective identification and traceability systems.
This guidance document provides practical instructions for implementing the Master UDI-DI for contact lenses, including its structure, how it should be assigned, labelled, and registered in EUDAMED.
Note: This document should be read alongside:
- Regulation (EU) 2017/745 (MDR)
- Commission Delegated Regulation (EU) 2023/2197, as amended by (EU) 2025/788
- Other MDCG UDI-related guidance documents
Key Updates in MDCG 2024-14 Rev. 1
- Page 4: Added reference to Regulation (EU) 2025/788 and a related footnote
- Page 4: Updated link to the latest consolidated version of the MDR
- Page 12: Included new reference to Regulation (EU) 2025/788 and the updated date of application for Master UDI-DI for contact lenses
- Page 12: Added references to: MDCG 2025-7 Position Paper MDCG webpage on “Master UDI-DI for highly individualised devices”
The guidance document can be accessed using the following link
