| Theme | UDI |
| Target Audience | Manufacturer |
| Products concerned | MD and IVD |
| Documents mentioned |
MDR (EU) 2017/745 Annex VI IVDR (EU) 2017/746 IMDRF/UDI WG/N48 FINAL: 2019 MDCG 2019-11 |
This document is intended to provide interpretations on how certain principles and examples are described in the IMDRF UDI Implementation Guide. This MDCG provides specific information on the status of IMDRF N48 Annexes E-I within the EU regulatory framework, with these annexes referring in particular to:
- Examples of unit of use and packaging configuration
- Feasibility issues related to the integrity of direct marking
- Examples of kits
- Examples of modifications to configurable medical devices
- Examples of UDI assignment for software