Unique Device Identifier Medical Device

Under the rule medical devices will be marked with a unique device identifier udi that will appear on the label and package of a device.

Unique device identifier medical device.

Food and drug administration fda created unique device identification often abbreviated udi a rule that requires medical device manufacturers to update their products with a unique device identifier that includes both device and production identifiers such as expiration date and lot or serial number. The united states food and drug administration fda implemented a unique device identification udi system to assign a unique identifier to all medical devices distributed in the us. Udis will be presented on device labels in both a human readable format and a machine readable format e g a barcode. A device identifier di and a production identifier pi.

A dedicated global identification protocol is needed to unambiguously identify medical devices in the healthcare supply chain. 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. The unique device identification system final rule udi rule requires device labelers typically the manufacturer to. The udi code unique device identifier provides all the standardized information related to the life cycle of the device.

The unique device identification udi system is intended to assign a unique identifier to medical devices within the united states and 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. The fda established the unique device identification system to adequately identify medical devices sold in the united states from manufacturing through distribution to patient use.

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. Gs1 standards can be used to support your udi implementation for all classes of. From its production to its final use to prove. Unique device identification udi the u s.

Include a unique device identifier udi on device labels and packages. A udi typically includes two segments.