Unique identification for similar products

The Basic UDI-DI is an identifier that links together medical devices as a 'family' that have the same characteristics around:

  • Purpose
  • Risk level
  • Basic design and manufacturing

Each device within the family still has its own unique identifier (UDI-DI). Basic UDI-DI helps manage similar devices more efficiently. 

This system is specific to the EU and helps with things like regulatory oversight and safety monitoring.

European Database on Medical Devices (EUDAMED)

Basic UDI-DI is an identifier introduced by the EU Commission as part of the UDI requirements of the EU Medical Device Regulations. It is the main key in the EUDAMED database and relevant documentation to connect families of devices. 

The EUDAMED database is made up of six modules and the Basic UDI-DI serves to connect these modules using a single identifier.

The Basic UDI-DI will appear in the database and on documents such as the declaration of conformity for the product certification.

Once the EUDAMED is in place, anyone entering the Basic UDI-DI will be able to access all the documents and reports and all the devices within the family of products. 

In GS1 standards, the Global Model Number (GMN) is the identifier that meets the requirement of the Basic UDI-DI.