EU Guide: Shelf Life, Expiration Date, Expected Lifetime/Useful Life, Service Life, Life Cycle
October 24, 2023
Swiss Federal Council: Drafting New Negotiating Mandate to Remain in the EU Single Market
November 9, 2023Commission 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.”
