With in-house barcode grading technology, we can optimize the label design, test out the labels, and provide reports so our customers don’t have to. Lastly, we have exceptional Pantone color expertise or the ability to match a device housing.
A long-term medical device customer needed to transition the labeling on products to new UDI labels that met specific FDA requirements. See how JN White® investigated the requirements, tested current labels, and determined what alterations needed to be made to meet the tough requirements.
Starting in 2013, the US Food & Drug Administration (FDA), the European Commission (CE), and other regulating bodies established new labeling requirements for medical devices. These are the Unique Device Identification, or UDI, requirements.
The goal is to increase patient safety, increase supply chain efficiencies, and improve the traceability of medical devices. These regulations were phased in over time, with all three levels of medical devices – Class III, Class II, and Class I – now in place.
As with many government regulations, the onus is on manufacturers of medical devices to ensure compliance. As one customer told us, “we don’t want to be in the label compliance business, but now we have to be – so help us make it as streamlined and painless as possible.”
Typical elements in the barcode data matrix include the following:
- GTIN – Global Trade Item Number (as provided by an issuing agency such as GS1)
- Manufacture Date
- Batch or Lot Number
- Serial Number
When it comes to producing the actual labels, your supplier needs the capabilities to manage, print, and check both 2D and FDA-accredited data matrix barcodes. That includes Variable Data Printing (VDP), the appropriate barcode encoding software, and a documented process to test the labels. In the case of an FDA audit, you need to be able to prove that the labels have graded out to the desired level. This must be supported by the appropriate records and documentation.
This ability to grade out the barcodes is essential, and it requires a specialized barcode grader. When selecting a label manufacturer, an important consideration should be whether they have these capabilities in house.
Another key element of the registration process relates to the design of the label itself.
Based on specific use requirements, labels often need to be much more than just scannable. There are issues of durability, temperature and humidity parameters, chemical resistance, abrasion resistance, legibility, visual appeal, etc. Substrates, adhesives, sizes, colors, overlaminates, and other elements need to be selected to ensure optimal performance. Then, just as with the scan testing, these need to be graded out and documented.
At JN White®, we work closely with our customers’ engineers to produce and test combinations of digitally printed labels using sub-surface printing, top surface printing, clear varnishes, clear overlaminates, and other techniques. We then perform the testing necessary to determine which material and design combination grades out the best versus the product requirements. All of this is documented appropriately so that you can go into the accredited agency’s portal and register these parts more quickly and easily, since all the information is organized for you.
Working with experts is imperative in this new world of UDI labeling. If you are just starting, we can help you learn more about it. Understand the codes, make sense of the regulations, and do it right.
While we understand that adhering to new regulations hardly tops anyone’s “favorite things to do” list, it’s important to ensure that you’re in line. We’re here to help.
My product is new and doesn’t have a GTIN number. How do I know if I need the UDI label?
While some devices are clearly covered by the regulations, some might not be so obvious. For instance, we have a customer who makes indoor tanning booths. Turns out these are indeed medical devices, as the UV they produce can be used as a treatment for rosacea, eczema, and other skin conditions. That said, it’s wise not to make any assumptions about the classification of your product. If you’re not sure, we suggest contacting an FDA-accredited agency such as GS1.
After checking, I found out that I need the UDI label. Now what?
The next step is to choose a label manufacturer that understands the considerations that apply to UDI labeling, both generally and in your industry. Asking the right questions can help you determine whether a manufacturer is well-equipped to help you through the UDI labeling process.
Has the label manufacturer worked with an FDA-accredited issuing agency?
Ideally, your manufacturing partner should understand how to help you work with an FDA-accredited issuing agency (GS1, ICCBBA, or the Health Industry Business Communications Council (HIBCC)).
Does the label manufacturer know the needs of your supply chain?
A good labeling partner can help you evaluate what information you need to put in your UDI barcode label, depending on the needs of your supply chain.
Does the label manufacturer have the capabilities to manage, print, and check both 2D and FDA-accredited matrix barcodes?
These capabilities include Variable Data Printing (VDP), the appropriate barcode encoding software, and a documented process to test the labels. In the case of an FDA audit, you need to be able to prove that the labels have graded out to the desired level. This must be supported by the appropriate records and documentation.
Does the label manufacturer understand design for the environment your label will live in?
Good manufacturers choose substrates, adhesives, sizes, colors, overlaminates and other elements based on environment-specific issues that can affect your label, including durability, temperature and humidity parameters, chemical resistance, abrasion resistance, legibility, visual appeal, etc.
We know that you might want to feel and interact with our work before committing to a project with us, which is why we’ve put together a variety of samples to send to you, free of charge.