Unique Device Identifier Udi

The unique device identification system final rule udi rule requires device labelers typically the manufacturer to.

Unique device identifier udi.

This element will be key for the traceability of devices in europe. The unique device identification udi system is intended to assign a unique identifier to medical devices within the united states and europe. 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. 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.

These codes are completely unique to the assigned device. A udi is a numeric or alphanumeric code that is assigned to a medical device. To be specific the concept of udi did appear on the imdrf guidance issued in 2013 this defined the basis of this new technology. The udi system consists of three core segments.

Include a unique device identifier udi on device labels and packages. 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. Unique device identifier udi global enterprise labeling system gels inventory control forms 29 inventory control form. 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.

Di device identifier a fixed section of the udi that identifies the specific model of device and the labeler. The udi consists of two parts.