Resources
UDI Guidance: Unique Device Identification (UDI) of Medical Devices
Category
Guidance Document
Organisation
International Medical Device Regulators Forum (IMDRF)
ID
IMDRF/UDI WG/N7FINAL:2013
Type
Standard
Access
Open
Status
Active
Created
Dec 2013
This document provides non-binding rules to support the regulation of medical devices. It offers a framework for regulatory authorities that intend to develop their unique device identification (UDI) systems.
Unique Device Identification system (UDI system) Application Guide
Category
Guideline
Organisation
International Medical Device Regulators Forum (IMDRF)
ID
IMDRF/UDI WG/N48FINAL:2019
Type
Standard
Access
Open
Status
Active
Created
Mar 2019
This application guide provides the details and specifications necessary for a harmonised approach to applying the requirements of the IMDRF UDI Guidance (IMDRF/WG UDI/N7Final:2013).