Within the EU Medical Device Regulations (MDR) a new identifier has been introduced to classify a group of products – the Basic UDI-DI (BUDI-DI).
As defined in the regulations:
“The BUDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.”
This BUDI-DI must now be assigned to a product before it can be submitted for market registration and approval by authorities. As a GS1 member you can use the GS1 Global Model Number (GMN) to meet this requirement.
From this webinar, you will gain:
And you'll have the opportunity to ask our experts questions to help you get the most from your membership.