Master UDI-DI for Contact Lenses: What Manufacturers Need to Know
Learn about the new Master UDI-DI for contact lenses: requirements, Eudamed registration, and mandatory compliance timeline.
The Master UDI-DI system is an essential development for the contact lens industry, providing a streamlined approach to traceability and ensuring compliance with the European Medical Device Regulation (MDR). The MDCG 2024-14 guidance document outlines clear steps for manufacturers and economic operators to implement this system, including assignment, labeling, and registration requirements. This move aims to enhance product traceability, safety, and transparency.
What is Master UDI-DI and Who Does it Apply To?
The Master UDI-DI is a unique identifier assigned to highly individualized medical devices, like contact lenses, that share similar clinical parameters (e.g., base curve, diameter). This identifier allows for improved traceability and ensures that contact lenses can be tracked effectively throughout the supply chain.
The system is designed to group contact lenses with the same combination of parameters under one Master UDI-DI, making it easier for both manufacturers and regulatory bodies to identify and track these devices.
Eudamed Registration Requirements
For full compliance with the MDR, contact lenses with Master UDI-DI must be registered in Eudamed, the European database for medical devices. Manufacturers must ensure that all products are properly listed, allowing for seamless reporting and vigilance in case of incidents. Eudamed registration will replace the previous use of UDI-DI for standard and made-to-order lenses.
Key Deadlines and Compliance Obligations
Mandatory Compliance by 2025:
The Master UDI-DI system must be fully implemented by November 9, 2025. While this deadline allows a transition period, manufacturers are encouraged to implement the system in advance, especially as Eudamed registration becomes mandatory.
Early Adoption:
Manufacturers can choose to implement the Master UDI-DI before the official deadline, ensuring they are ahead of the regulatory curve.
Benefits of the Master UDI-DI System
Enhanced Traceability: The Master UDI-DI provides clearer traceability for contact lenses, improving safety monitoring and recall processes.
Streamlined Compliance: By adopting the system early, manufacturers can ensure smoother compliance with upcoming regulatory requirements.
Better Market Access: Proper UDI implementation can simplify the market entry process for contact lenses in Europe and ensure product safety.
Conclusion
The Master UDI-DI for contact lenses is an important regulatory development that enhances device traceability, safety, and market transparency. Manufacturers must be prepared for the mandatory implementation in 2025, but early adoption is highly recommended.
Need Assistance?
If you’re a manufacturer or economic operator and need support with Master UDI-DI compliance, we’re here to help. Contact us to learn more about the new guidelines and how we can assist with registration in Eudamed and other compliance requirements.
