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EU contact lens identification rule takes effect for manufacturers
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The European Union’s new system for assigning device identifiers to contact lenses applies from November 9. The European Commission moved the start date back a year from November 9, 2025, to give manufacturers time to adapt their systems for assigning the codes. [evidence-1]
Under the system, manufacturers group standard contact lenses that share specified design characteristics, including the lens’s base curve and diameter. They assign the group a common device identifier called a Master UDI-DI. EU Medical Device Coordination Group guidance says use of the new identifier was voluntary before the application date. [evidence-2]
The change matters to Indian manufacturers that place covered contact lenses on the EU market. The requirement concerns how those products are identified in that market, regardless of where the manufacturer is based. [evidence-2] [evidence-3]
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