There are many medical devices in the market of the United States and there is a possibility of more devices in the near future. The people who are preparing to introduce a new medical device into the market must ensure that the unique device identifier is labeled in the device with the help of udi toolkit.
What is the unique device identifier?
Every device will have the device type and the production variables that have to be labeled in order to distinguish one medical device from another. The device type will have the model number and the version whereas the production variables include a serial number, production, and expiration date of the medical device.
Requirements of Unique Device Identifiers
All the manufacturers have to follow a few requirements before releasing their medical device to the outside world with the help of the udi toolkit.
- The medical device labelers should request a Global model number that is GMN first. This number will be helped to describe the version of the product or the model of the product based on the attributes that are derived from the FDA.
- The medical device labelers have to request GTIN which is the Global Trade Item Number in order to fulfill requirements under UDI-DI.
- This Global Trade number is also called a Global supply chain solution as it is possible to trace the product when it is priced or ordered or at any point of the supply chain without any effort.
- Another requirement is that under UDI-PI there should be three production identifiers on the label for an expiration date, serial number, and manufacture date.
How to apply a UDI code on any medical device using udi toolkit?
After generating a Unique Device Identifier by following all the requirements notified by the FDA each UDI code has to be applied in human-readable format and also machine-readable form like barcodes. If the device or collection of devices is going to be dispatched in a package, all the items in the package should be given to all applicable items.
For devices that are going to be reused or reprocessed this UDI is not used. Instead, there will be direct marking done on them. The manufacturer or the labeler should determine whether the product comes under direct marking criteria or they come under the existing exception where UDI is done using udi toolkit.
For the Single-unit, package one GTIN will be given and for the multiple unit packages new GTIN will be given and for the package case, another GTIN will be assigned.
This Unique device identifier process will come completely into effect in several stages over a period of several years in order to ensure smooth implementation. The costs and burdens that are required for this smooth implementation will also have to be spread across the globe. So as of now, there is no specific timeline under which every device has to be UDI compliant.
For Direct Marking, a 2-year extension is given in both the US and the EU. In the USA the devices that are already in the market have exceptions until the end of their life span.