(Utkast) Delegert kommisjonsforordning (EU) .../… av 16. april 2025 om endring av delegert kommisjonsforordning (EU) 2023/2197 med hensyn til anvendelsesdato
Unik utstyrsidentifikasjon for kontaktlinser: endring av anvendelsesdato
(Draft) Commission Delegated Regulation (EU) .../… of of 16 April 2025 amending Delegated Regulation (EU) 2023/2197 as regards the date of application
Utkast til delegert kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering 16.4.2024
Bakgrunn
(fra kommisjonsforordningen)
(1) Commission Delegated Regulation (EU) 2023/2197 amended Regulation (EU) 2017/745 as regards the assignment of Unique Device Identifiers (UDI) for contact lenses as highly individualised devices, by introducing the ‘Master UDI-DI’ solution. Delegated Regulation (EU) 2023/2197 is to apply from 9 November 2025.
(2) The Subgroup on Unique Device Identification of the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745 identified a need to develop guidance to ensure effective and harmonised implementation of the Master UDI-DI solution for contact lenses.
(3) The MDCG endorsed guidance document MDCG 2024-1 ‘Guidance on the implementation of the Master UDI-DI solution for contact lenses’. The Commission published that guidance document on its website in November 2024, one year before the date of application of Delegated Regulation (EU) 2023/2197.
(4) Given the clear need for availability of that guidance document for operators to plan their implementation efforts and resource allocation on such complex technical matter, in order to allow them to adequately implement the Master UDI-DI solution for contact lenses and adapt their internal systems and technologies for UDI assignment, as well as to ensure the necessary level of legal certainty on the market and a smooth transition to the new rules, it is appropriate to defer the date of application of Delegated Regulation (EU) 2023/2197 by one year.
(5) Delegated Regulation (EU) 2023/2197 should therefore be amended accordingly,