Unique Device Identification or UDI is a regulatory requirement first enacted by the US FDA, and now adapted by regulatory agencies around the world. UDI enhances patient safety by identifying each medical device product with a static device identifier denoting the device labeler and the specific model or version of a device and the dynamic product identifier which identifies the expiration date, serial number, manufactured date or the lot/batch number of the device. With UDI in place, product recalls can be handled more efficiently and health care providers can make more informed treatment decisions for patients. By playing a part in the digital supply chain, UDI can help fight counterfeit or illicit products entering the marketplace.
The UDI is created through an approved issuing agency. This identifier, along with additional product data elements are part of the Health Authority submission requirement. Medical device manufacturers carry this obligation for specific regions where their devices are marketed.
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