The unique device identification udi system is intended to assign a unique identifier to medical devices within the united states and europe.
Unique device identifier udi.
The udi must include a device identifier di and may contain a production identifier pi.
These codes are completely unique to the assigned device.
The unique device identification system final rule udi rule requires device labelers typically the manufacturer to.
Include a unique device identifier udi issued under an fda accredited issuing agency s udi system on device labels device packages and in some instances directly on the device.
The udi consists of two parts.
Include a unique device identifier udi on device labels and packages.
The first is the udi which is a unique number assigned to the version or model of a device that is required on all packaging labeling of finished goods.
The udi or unique identification number europe as there is also one in the usa is one of the new things that come with the new eu mdr 2017 745 and ivdr 2017 746.
This element will be key for the traceability of devices in europe.
To be specific the concept of udi did appear on the imdrf guidance issued in 2013 this defined the basis of this new technology.
It was signed into law in the us on september 27 2007 as part of the food and drug administration amendments act of 2007 the eu acted to adopt udi and on april 5 2017 under the eu medical device regulation mdr and in vitro diagnostic regulation.
A unique device identification udi system is intended to provide single globally harmonized positive identification of medical devices through distribution and use requiring the label of devices to bear a globally unique device identifier to be conveyed by using automatic identification and data capture and if applicable its human.
Di device identifier a fixed section of the udi that identifies the specific model of device and the labeler.
Udi consists of a unique code identifier that includes information specific for each device model as well as production data lot or batch number the serial number and or expiration date and an fda created database that will include a standard set of identifying elements for each udi.
