Understanding the UDI system

The new Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices requires more rigorous traceability of medical devices to increase manufacturer transparency towards patients. This requirement gave rise to the UDI system. The UDI system is made up of several codes that manufacturers will need to enter into a new public database: EUDAMED.

This system can be difficult to grasp, which is why we suggest reviewing together the different parts of the UDI 💭

• UDI: Unique Device Identification

It is represented by a barcode consisting of a static part (UDI-DI) and a dynamic part (UDI-PI)

• UDI-PI:

Code identifying the production of the MD (e.g. batch number, release date, expiry date…) and therefore representing the dynamic part of the UDI.

• UDI-DI:

Code uniquely identifying the MD (the specific model!) and therefore representing the static part of the UDI.

• Basic UDI-DI:

Code identifying a group of similar MDs with variations that do not impact their basic application.

E.g.: A telemonitoring software MD with several variants (one variant per pathology) will have a single Basic UDI-DI. However, each variant will have its own UDI-DI.

💡 To obtain UDI-DI and Basic UDI-DI codes, it is necessary to approach authorised international coding bodies, such as GS1. The Basic UDI-DI is assigned free of charge and can be done independently on the GS1 website. The UDI-DI, however, is a paid service that can only be obtained after joining GS1. It is also important to note that in addition to the GS1 subscription, an additional fee is charged for each product UDI-DI requested.