MDCG updates on lenses and frames UDI requirements implementation

Article summary

The Medical Device Coordination Group (MDCG) has published a Position Paper on the implementation of unique device identification (UDI) requirements for contact lenses, spectacle frames, spectacle lenses and ready readers. UDI requirements were introduced via Article 27 of Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), and this MDCG paper provides clarification on the implementation of the UDI requirements for the aforementioned medical devices ‘until solutions are finalised’. The paper outlines three clarifications for UDI assignments, UDI carrier labelling, and UDI and device registration.