Theme UDI
Target Audience Manufacturers, systems and procedure packs producers, kit producers  
Products concerned MD, IVD
Documents mentioned

MDR (EU) 2017/745

IVDR (EU) 2017/746


MDCG 2018-1

MDCG 2018-6

MDCG 2021-19

MDCG 2021-27


IMDRF Unique Device Identification system (UDI system) Application Guide
Appendix G, as endorsed at EU level in MDCG 2021-10

This document is in the form of questions and answers relating to the unique identification system on medical devices (UDI). It provides further details for operators on the application and practical implementation of the UDI requirements.

The questions and answers are structured around the following topics: UDI-DI, basic UDI-DI, UDI support on labelling, UDI rules for systems and procedure packs and configurable devices, retailing and sampling of devices for marketing purposes, rules for kits and UDI and the link between UDI and Eudamed