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Basic UDI-DI for the EU Medical Device Regulations

Thursday 3 December 2020

2:30 PM to 3:00 PM

Online webinar

Member price: Free

Non-Member price: Free

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Add to Calendar 2020-12-03 14:30:00 2020-12-03 15:00:00 Basic UDI-DI for the EU Medical Device Regulations 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. United Kingdom GS1 UK gs1uk@mailinator.com Europe/London public
Overview

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.

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Learning outcomes

From this webinar, you will gain:

  • A deeper understanding of Basic UDI-DI as outlined in the EU MDR
  • How to ensure your medical devices are compliant with the updated requirement

And you'll have the opportunity to ask our experts questions to help you get the most from your membership.

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