October 23, 2023
The European Medical Devices Regulation (Regulation 2017/745, MDR) requires each specific model of a device to have its own unique UDI-DI. Since contact lenses come in a broad variety, this would require manufacturers to assign a great number of UDI-DIs. Stakeholders urged the European Commission (EC) to adopt exceptions to the UDI-DI assignment to contact lenses.
New delegated regulation published to amend Annex VI, Part C
A new delegated regulation is published in the Official Journal of the European Commission (OJEU):
Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses
With the adoption of this new regulation, the EC appears to have acknowledged this exceptional situation. The EC feared the large number of UDI-DIs would lead to a flood of device registrations in EUDAMED, and as such the EC adopted this delegated regulation.
Specific Provisions to Annex VI, Part C, Section 6.6
With the adoption of this delegated regulation, the MDR (EU) 2017/745 is amended, and the following new text is added:
“In Part C of Annex VI to Regulation (EU) 2017/745 the following sections are added:
Highly individualized devices
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 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.
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.”
This is a welcome change for contact lens manufacturers. This delegated Regulation applies from November 9. 2025.
While this legislative revision applies only to contact lenses, it suggests the EC is amenable to revising the legislation and recognizes that there are “highly individualized devices” that may be exempt from the individual UDI-DI. Only time will tell if there are additional devices that are similarly considered “highly individualized devices.”
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