Unique Device Identification (UDI) Systems Expansion in Europe

The implementation of Unique Device Identification (UDI) systems in markets beyond the US is increasing, as the European Commission is planning to publish a guidance document on UDI under the MDR and IVDR in March 2018.

It became clear that most markets will have a UDI system within five years . Although it will be possible to to use a single UDI code in all markets, there will be different datasets linked to that code in different markets.

What do you need to Know about UDI?

  • UDI stands for Unique Device Identification. This is a numeric of alphanumeric code, human and machine readable and based on globally accepted standards, for positive identification of medical devices, up to the level of batch or serial number.
  • The UDI consists of the UDI-DI for device identification of the unit of use and the UDI-PI for the production identifier. This combination of codes will assist in the identification of a particular device in the distribution chain up to the level of production series.
  • The UDI-DI code will be linked to a database (UDID) and the UDI-PI should be kept by the economic operators and institutions using the devices.
  • The UDI will make the device traceability easier.
  • The UDI is an additional requirement to labelling requirements and it does not replace the requirements related to the device name, name and address of the manufacturer, warnings, etc.
  • Each level of packaging shall have its own UDI-DI for further identification of specific packages in the supply chain.  However, shipping containers are excluded from this rule.
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