What Is A Unique Device Identifier?Article 2 (15) of the MDR 2017/745 defines a Unique Device Identifier’ (‘UDI’) as ‘a series of numeric or alphanumeric characters that are created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market’
Annex VI (Part C) has the following definitions for UDI:
- Basic UDI-DI: The Basic UDI-DI is the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.
- UDI-DI: The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the ‘access key’ to information stored in a UDI database.
- UDI-PI: The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.