19/12/2024
On November 26, 2024, the Medical Device Coordination Group (MDCG) published MDCG Guide 2024-14, a key document for contact lens manufacturers. The guidance provides operational instructions for implementing the Master Unique Device Identifier (Master UDI-DI) code, introduced by Delegated Regulation (EU) 2023/2197 of July 10, 2023. This tool is designed to simplify the identification of contact lenses, a device category characterised by various design and clinical combinations.
Background and Regulatory Framework
The MDR Regulation (EU) 2017/745 introduced the UDI system, which requires all Medical Devices (except custom-made ones) to be identified through a basic UDI-DI, a UDI-DI and a UDI-PI. In addition, manufacturers must ensure that UDI codes are displayed on device labels, on all levels of the outer packaging and in the European Eudamed database to ensure product traceability. In essence, each specific model of a medical device must have its own unique UDI-DI.
In the case of contact lenses, the great variety of possible models and combinations would entail handling many UDI-DIs, making the system complex. To simplify and overcome these difficulties, Delegated Regulation (EU) 2023/2197 introduced the concept of Master UDI – DI (MUDI), which allows contact lenses with similar characteristics to be grouped while maintaining product traceability and safety.
The updates can be found in new sections in Annex VI, Part C of the MDR Regulation:
- 6. Highly customised devices
- 6.1. Contact lenses
- 6.1.1. Standard contact lenses
Contact Lenses and UDI-DI Masters
Contact lenses with the same combination of clinical and design parameters (e.g. base radius and diameter) should be grouped under the same Master UDI-DI (MUDI).
MDCG Guide 2024-14 explains how to assign MUDI according to lens type, standard or custom-made. For example, a UDI-DI must be assigned to standard contact lenses that have the same combination of design parameters, including at least the base curve and diameter, i.e. the MUDI is linked to a group of design parameters. The labelling must include AIDC (Automatic Identification and Data Capture) and HRI (Human Readable Interpretation) codes, compliant with GS1 standards, thus ensuring complete traceability of the devices.
The MUDI must be updated in case of changes that may affect the identification of the device, such as changes in design parameters, changes in trade name, version or model, updates on labelling (e.g. disposable device or sterilisation).
Manufacturers must include the complete UDI in surveillance reports such as the Manufacturer Incident Report (MIR).
Timeframe for Application
The UDI-DI Master for contact lenses will become mandatory as of November 9, 2025, but manufacturers can voluntarily adopt it already during the transition period.
MDCG Guide 2024-14 is an essential reference for contact lens manufacturers, providing a clear framework for implementing the UDI-DI Master and ensuring compliance with MDR requirements.
For more details, see the full guidance: MDCG 2024-14: Guidance on the implementation of the Master UDI-DI solution for contact lenses
>>> Preparing in advance for the November 9, 2025 deadline is crucial. Thema’s regulatory experts offer comprehensive support in achieving labelling compliance for all Medical Devices, including contact lenses.
