Overview of EU UDI Requirements

Are you ready for UDI in the EU?

The EU Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR)have been adopted on 5 April 2017 and define the requirements for the EU UDI system.

GS1 standards are enabling healthcare manufacturers from around the world, to create and maintain UDI numbers by following the EU Regulations and the GS1 General Specifications. According to the Regulations, a UDI number must be applied to the medical device label, its packaging and, in some cases, the device itself.

Download the brochure "UDI in Europe"

The Basic UDI-DI

A new concept has been introduced by the EU Regulations: the Basic UDI-DI, that allows to group regulated medical devices within EUDAMED.

GS1 has developed a new key to support the implementation of the Basic UDI-DI: the Global Model Number (GMN).

The latest version of the GMN is available here.

To calculate the GMN check characters or to verify your GMN (Basic UDI-DI), you can use the tool that GS1 has developed on the GS1 Global Office webiste. Click here to access it.

Required product data must be submitted to EUDAMED, the EU regulatory database for regulated medical devices.