(Under forberedelse) Delegert kommisjonsforordning (EU) .../... om endring av europaparlaments- og rådsforordning (EU) 2017/745 med hensyn til tildeling av entydige utstyrsidentifikasjonskoder for brilleinnfatninger, brilleglass og lesebriller som er klare til bruk
Unik utstyrsidentifikasjon for briller
(In preparation) Commission Delegated Regulation (EU) .../... amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for spectacle frames, spectacle lenses and ready-to-wear reading spectacles
Utkast til forordning lagt fram av Kommisjonen 30.1.2025 med tilbakemeldingsfrist 27.2.2025
Bakgrunn
(fra Kommisjonens initiativ av 30.1.2025)
Medical devices - spectacle frames, lenses and ready-made reading glasses (unique identifiers)
The EU has a unique device identification (UDI) system in place to ensure that medical devices can be traced should the need arise.
However, for certain devices the multiple types of products have led to a disproportionately high number of identifiers being assigned, with few regulatory or safety benefits.
This initiative therefore aims to group devices with clear clinical similarities, e.g. spectacle frames, lenses and ready-made reading glasses, under the same identifier: ‘Master UDI-DI’.
Draft act
Feedback period: 30 January 2025 - 27 February 2025
Draft delegated regulation - Ares(2025)725943