EU: New Approach Application Date for Contact Lenses' UDIs Scheduled on 9 November 2025

According to Regulation (EU) 2017/745, manufacturers are required to assign a Unique Device Identification (UDI) before placing their devices in the market, except for custom-made devices. Each UDI consists of a Unique Device Identification-Device Identifier (UDI-DI) and a production identifier (UDI-PI) and these data were assigned specifically to the devices’ model and manufacturer.

Contact lenses are known for many variants due to the high number of clinical parameters and many UDI-DI were generated for almost similar contact lenses. Hence, the individualized UDI-DI as regulated under Regulation (EU) 2017/745, had caused system overwhelm, proliferation of the UDI-Dis, and disproportionation when contrasted with the safety risk of the contact lenses.

Therefore, an amendment was decided to prevent different DI assigned to similar contact lenses and shall be implemented starting from 9 November 2025:

• Standard contact lenses

A UDI-DI shall be assigned to the standard contact lenses under the same combination of contact lens design parameters, including at least the base curve and diameter (“Master UDI-DI”)

A new Master UDI-DI shall be required if there are any changes in the combination group

• Made to order contact lenses

A UDI-DI shall be assigned to the standard contact lenses under the same combination of contact lens design parameters, including at least the base curve and diameter (“Master UDI-DI”)

A new Master UDI-DI shall be required if there are any changes in the combination group

The European Commission encourages manufacturers to start implementing the Master UDI-DI according to the amended regulation.

Source: European Commission (EC)

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