GLOSSARYEU
Unique Device Identifier (EU)
A series of numeric or alphanumeric characters, created through internationally accepted device identification and coding standards, that allows unambiguous identification of specific devices on the market. Under the EU MDR the UDI has two parts, a device identifier and a production identifier.
Parts and registration
- UDI-DI
- The device identifier, specific to a manufacturer and a device. The identifier gives access to the information in Part B of Annex VI.
- UDI-PI
- The production identifier. It identifies the unit of device production and, if applicable, the packaged devices.
- Basic UDI-DI
- Before placing a device on the market, the manufacturer assigns a Basic UDI-DI to it and provides it to the UDI database with the other core data elements.