In November 2024, the Medical Device Coordination Group (MDCG) released "MDCG 2024-14 - Guidance on the implementation of the Master UDI-DI solution for contact lenses (November 2024)" detailing the implementation of the Master UDI-DI (Unique Device Identification - Device Identifier) solution for contact lenses. This guidance is essential for manufacturers, healthcare providers, and other stakeholders involved in the production, packaging, and regulation of contact lenses in the European market.
Standard contact lenses (covering both standard soft contact lenses and rigid gas permeable (RGP) contact lenses): mass-produced contact lenses which are generally held in stock by the manufacturer / distributor / eye care professional and have a limited range of parameters. Example: standard soft daily disposable contact lenses.
Made to Order contact lenses (soft or rigid): lenses where (part of) the production process is initiated based on a specific individual order. These typically have a wide range of parameters. Example: lathe cut 3-monthly made-to order lens.
Master UDI-DI: The primary identifier for a group of products with similar characteristics, such as a range of prescription contact lenses with the same design and intended use.
The guidance aligns with the Medical Devices Regulation (MDR), ensuring better traceability and safety of contact lenses through a structured UDI system. Below is an overview of the key sections and recommendations from the guidance.
The guidance aims to support the implementation of the Master UDI-DI solution, a critical component of the MDR. It applies to both standard and made-to-order (MtO) contact lenses, addressing the specific requirements for UDI assignment, labeling, vigilance reporting, and registration in Eudamed (European Databank on Medical Devices).
Manufacturers are required to register contact lenses and their respective UDI-DIs in Eudamed, ensuring compliance with MDR Article 29. Key considerations include:
Accurate and timely data entry.
Regular updates to reflect changes in product specifications or packaging.
Vigilance Reporting
Regulation Contact Lenses: For lenses falling under MDR requirements, manufacturers must ensure vigilance reports include the Master UDI-DI for proper identification during adverse event tracking.
Legacy Contact Lenses: For contact lenses still marketed under the previous Directives, manufacturers are encouraged to adopt the UDI-DI system to facilitate seamless reporting and traceability.
Manufacturers and economic operators must fully implement the Master UDI-DI system by the end of December 2025. The phased approach ensures a smooth transition for legacy products while meeting MDR obligations.
By emphasizing standardized identification, vigilance reporting, and device registration, the document ensures better safety, transparency, and traceability in the contact lens industry.
For further details, refer to the full guidance document here.
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