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.