The European Union has introduced a new initiative for a Master Unique Device Identification (UDI) Device Identifier (DI) (Master UDI-DI) for highly individualized contact lenses. The UDI system is designed to improve traceability and accountability for medical devices, including contact lenses. This proposal is product-specific and seeks to streamline the registration process for manufacturers and improve patient safety. Feedback on the proposed Master UDI-DI may be provided until April 19th.
The proposed Master UDI-DI for highly individualized contact lenses is a significant step forward in medical device regulation. Under this initiative, not every individual lens would be assigned a UDI-DI. Lenses will be grouped with a Master UDI-DI. “Master UDI-DI is intended as the identifier of a group of highly individualized devices (i.e. contact lenses) presenting specific similarities with respect to defined clinically relevant Parameters”.
While this initiative is specific to contact lenses, it raises questions about the potential for a Master UDI-DI for other highly individualized medical devices. The European Commission has already received comments on this initiative, and if your products fall under a similar category, it may be worth considering commenting on the proposed Master UDI-DI.
As with any new regulation, it is essential to stay informed and up-to-date. Delegated acts can be found on the Commission website. Before assigning a UDI and registering your product in Eudamed, it is recommended that you check whether there are any Master UDI-DI requirements for similar products.
Don't miss the opportunity to provide feedback on this proposed regulation. Comments are open until April 19th, so be sure to have your say on this important matter!