The European Medical Device Regulations (Regulation 2017/745, MDR) require that each particular device model has its own UDI-DI.
Contact lenses vary widely, requiring the manufacturer to specify a number of UDI-DI.
The EC adopted this mandate out of concern that a higher number of UDI-DI would lead to a surge in medical device registrations in EUDAMED.
The amendment takes effect on November 9, 2025, and allows contact lens manufacturers to assign master UDI-DI to specific products instead of individual UDI-DI, reducing the associated administrative burden.
In Part C of Annex VI to Regulation (EU) 2017/745 the following sections are added:
‘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.’
Please refer to the link below for details.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AL_202302197
If you have any questions about medical device in EU,
Please contact us with the below.
info@jnmglobal.net
'JNM Global > Medical Device' 카테고리의 다른 글
| China NMPA, updates medical device classification (0) | 2023.11.02 |
|---|---|
| Indonesia medical device MoH certification (0) | 2023.11.01 |
| Mexico in vitro diagnostic medical device Cofepris certificate (0) | 2023.10.27 |
| Three new UK Approved Bodies to certify medical devices announced by the MHRA (0) | 2023.10.10 |
| Brazil ANVISA, Revised medical device import business (0) | 2023.10.04 |