UE – MDCG 2024-14 – Guidance on the implementation of the Master UDI-DI solution for contact lenses – October 2024

2 Dec 2024 | MDCG

Theme Highly individualised devices UDI 
Target Audience Manufacturers, notified bodies 
Products concerned Highly individualised MD : contact lenses 
Documents mentioned

MDR (EU) 2017/745 – Annex VI part C 

MDCG 2018-1 

This Guide details the procedures for allocating a master UDI-DI for contact lenses, which are highly individualised devices, and in particular the following provisions: 

      • Allocation of the master UDI-DI for standard contact lenses and those manufactured to order 
      • Affixing the master UDI-DI to the container, packaging levels and packaging variants 
      • Use of the master UDI-DI in declarations of vigilance (MIR) for RDM-compliant contact lenses and contact lenses that are legacy devices 
      • Timetable for application of the UDI-DI master 
      • Registration of devices in Eudamed