CE Europäische Union
  • 11 - Medizintechnik

Certain products without an intended medical purpose listed in Annex XVI of Regulation (EU) 2017/745 on medical devices and standard and made to order contact lenses.

Draft Commission Delegated Regulation amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses; (7 page(s), in English)

The proposed Regulation is a Delegated measure adopted pursuant to Article 27 (10) (b) of Regulation (EU) 2017/745 whereby the Commission is empowered to amend Annex VI of that Regulation in light of international developments and technical progress in the field of Unique Device Identification. In order to resolve the implementation issue concerning the registration of UDI-DI data elements in Eudamed for highly individualised devices, and in particular contact lenses, the Commission is empowered to establish a specific UDI-DI assignment rule for such devices. This solution will allow a more effective implementation of the UDI system at European level.