Basic UDI-DI and FSNs

Within the EU MDR (Medical Device Regulation), a new identifier has been introduced to classify a group of products – the Basic UDI-DI (BUDI-DI).  

BUDI-DI is the primary identifier of a device model assigned at the level of the device unit of use and must now be assigned to a product before it can be submitted for market registration and approval by authorities in the EU.

This session will explore how the GS1 Global Model Number (GMN) can be used to meet this requirement, and what UDI requirements are needed for MHRA Field Safety Notices (FSNs).

This webinar is part of a three-part series aimed at manufacturers and suppliers of pharmaceuticals and medical devices.

Each series is focuses on a selected elements of product identification covering everything from understanding GS1 standards and forming GTINs, to encoding production information and producing high-quality barcodes.

You can find out more about the series via the link below.