Manufacturers placing contact lenses on the European Union market must now use the bloc’s Master UDI-DI identification solution, after the revised application date arrived on Monday.
The system adapts the EU Medical Device Regulation’s unique-device-identification rules to products that can be supplied in very large numbers of variations. A Master UDI-DI groups contact lenses with defined design parameters under a common identifier, while preserving the traceability structure required by the medical-device regime.
Commission Delegated Regulation (EU) 2023/2197 created the contact-lens rules. A later amendment deferred their application by one year, to 9 November 2026, after the Medical Device Coordination Group said manufacturers needed harmonised guidance and sufficient time to adapt systems and technologies.
The change is now an operative compliance requirement, not a fresh policy announcement. Manufacturers must assign identifiers in accordance with the regulation and the applicable guidance, while distributors, importers and other economic operators remain subject to their own Medical Device Regulation duties.
The Commission has also developed a related Master UDI-DI approach for spectacle frames, spectacle lenses and ready-to-wear reading spectacles, but those product-specific timelines are separate. Monday’s commencement concerns contact lenses under the delegated regulation.
