The Unique Device Identification
A Unique Device Identification (UDI) system is intended to provide single, globally harmonized positive identification of medical devices through distribution and use, requiring the label of devices to bear a globally unique device identifier (to be conveyed by using Automatic Identification and Data Capture and, if applicable, its Human Readable Interpretation) based upon the standard with the UDI-DI (Device Identifier) of that unique identifier being also linked to a jurisdiction-specific public UDI database (source: International Medical Device Regulators Forum (IMDRF): http://www.imdrf.org).
The Global Model Number enables users to uniquely identify the product model through the entire life cycle of the product: design - production – procurement – use – maintenance - disposal.
In the European Union (EU), the GMN supports the implementation of the requirements of the Basic UDI-DI under the EU Unique Device Identification (UDI) regulations on medical devices and on in vitro diagnostic medical devices. The Basic UDI-DI is the main key for medical devices records in the UDI regulatory database EUDAMED and is referenced in relevant certificates and in EU declarations of conformity.
To find out more information on the Unique Device Identification (UDI) Regulations, this includes US and EU requirements, please use this link
To find out more information on the GMN, please click on the link below