Unique Device Identifier Medical Device

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.

Unique device identifier medical device.

The unique device identification udi system is intended to assign a unique identifier to medical devices within the united states and europe. A dedicated global identification protocol is needed to unambiguously identify medical devices in the healthcare supply chain. 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. 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 identification udi the u s. Include a unique device identifier udi on device labels and packages. A udi typically includes two segments. The international needs for patients safety have led many countries to adopt some regulations for identifying the medical devices contact lenses bandages scalpels syringes prosthesis vitro diagnostic devices.

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. To be specific the concept of udi did appear on the imdrf guidance issued in 2013 this defined the basis of this new technology. This element will be key for the traceability of devices in europe. 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.

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. The udi code unique device identifier provides all the standardized information related to the life cycle of the device. 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. A udi is a unique numeric or alphanumeric identification code assigned to medical devices by the labeler e g manufacturer of the device.

Udis will be presented on device labels in both a human readable format and a machine readable format e g a barcode. The unique device identification system final rule udi rule requires device labelers typically the manufacturer to.