SPECTARIS and EUROM Secure Regulatory Clarity on MDR UDI Deadlines for Eyewear Manufacturers

SPECTARIS Consumer Optics and EUROM Optical Industries successfully addressed a conflict in the EU Medical Device Regulation (MDR) that risked forcing eyewear manufacturers into non-compliance. The issue involved EUDAMED registration deadlines preceding the technical feasibility of Master UDI-DI implementation, potentially exposing producers to sanctions for up to 30 months. Following advocacy efforts, the European Commission published an official position paper on July 10 clarifying that manufacturers may register products with Master UDI-DI before mandatory deadlines if technically feasible, but are not required to do so. Alternatively, existing identifiers like GS1 codes remain valid until the specific Master-UDI deadlines: November 9, 2026, for contact lenses and September 2028 for eyeglass frames, lenses, and ready-made readers. This clarification provides essential legal certainty and audit readiness for the optical industry.