Starting in 2013, the US Food & Drug Administration (FDA), the European Commission (CE), and other regulating bodies established new labeling requirements for medical devices.
The goals were to increase patient safety, increase supply chain efficiencies, and improve the traceability of medication and medical devices. These regulations were phased in over time, with the first two levels (for Class III and Class II medical devices) already in place, and the final level (for Class I Medical Devices) due in September 2018.
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.
How to check if you need the UDI label
Finding out if you need the UDI label only takes three simple steps:
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, email firstname.lastname@example.org we’ll help you determine whether the label is required.
After checking, I found out that I need the UDI label. Now what?
The next step is to choose a label manufacturer that understand 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?
Does the label manufacturer know 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?
Does the label manufacturer understand design for the environment your label will live in?
Still not sure if you need UDI labeling? Let us help.
Working with experts is imperative in this new world of UDI labeling. If you are just starting, we can help you understand the codes, make sense of the regulations, and do it right. And if you are already working in this regulatory space, we can step right in and help streamline the registration and production processes.
Ken Boss is the Vice President of Sales & Marketing at JN White™, a leading ISO 9001:2015 and ITAR certified manufacturer. He is an expert in the design and production of graphic overlays, membrane switches, user interfaces, control panels and custom labels. To see additional insights from Ken, please visit www.jnwhiteusa.com/blog.