Commission Delegated Regulation (EU) 2023/2197, on “Master UDI-DI” was published in the Official Journal of the EU (OJEU) on 20 October 2023. It is available: HERE

It will enter into force 20 days after publication to the OJEU and will apply from 9 November 2025.

With this, the new Master UDI-DI term and principle will be implemented. It is initially only applicable to contact lens manufacturers. However, the EU Commission stated that Master UDI-DI may also be applied to other types of “highly individualized devices” in the future. 

For an overview of Master UDI-DI, and its impact on contact lens manufacturers, please read our post from 23 March 2023: New EU Commission Proposal: “Master UDI-DI” for “highly individualized devices”

What specifically has been added to the MDR?

The following has text been added to the EU MDR 2017/745, Part C of Annex IV:

“6.6.   Highly individualised devices

6.6.1.   Contact lenses

6.6.1.1.   Standard contact lenses

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

In addition to the requirement laid down in Section 3.9, a new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters referred to in the first paragraph.

6.6.1.2.   Made to order contact lenses

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

In addition to the requirement laid down in Section 3.9, a new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters referred to in the first paragraph.”