With 2017 coming to an end, it is a good time to preview what is upcoming in 2018 for medical device labeling in the US.
The Unique Device Identification Rule has been a popular topic over the past two years and it has achieved many milestones, requiring medical device manufacturers to follow labeling on Class Two and Class Three devices.
We head into 2018 with more regulations and requirements to stay informed on.
Class One devices will have these same specifications and regulations by 2020. While Class One devices are less threatening and low risk items, they still present companies with challenges in becoming compliant. The sheer volume of class one devices provides the challenge, more products and more organizations that need to participate in UDI compliance.
As we have learned over the years it is important to prepare for these requirements. Pragmatyxs has the experience and resources to assist your company in getting compliant and develop an accurate and quality labeling solution.