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Focus on UDI

Publié le 09/02/2023 - Regulatory affairs

Basic UDI-DI, UDI-DI, UDI-PI, UDI … It is easy to get in a complete muddle when using these codifications that are now required by EU Medical Device Regulation 2017/745.

What are the differences between these codes? Which one should be applied directly to the medical device?

UDI (Unique Device Identification) aims at strengthening medical device traceability along its lifecycle.

When it comes to UDI, one has to know that the sequence is a combinaison of two codes: UDI-DI and UDI-PI: UDI = UDI-DI + UDI-PI

  • UDI-DI: static identifier, attached to a specific medical device part number.
  • UDI-PI: dynamic identifier, attached to a specific production batch.

The UDI is directly applied to the medical device and/or its packaging. The manufacturer has to record every UDI that he creates.

What about Basic UDI-DI?

Well, this one is a bit different. Its being used only for regulatory purpose, for identifying medical devices that belong to the same product family (for instance devices that shares the same EU declaration of conformity) in the EUDAMED database. The Basic UDI-DI is never applied to the medical device itself. More information are available in MDCG 2019-4 guidance.