New White Paper: Navigating Global Med Device Labeling Regulations
Just as you’ve come to grips with the FDA’s Unique Device Identification (UDI) system, along comes the European Union’s version—and a new set of labeling requirements. The EU’s recently published Medical Device Regulation (MDR) has similar components of UDI in the States, but it also has some fundamental differences you’ll need to pay attention to, especially if you do any kind of business abroad.
The global rollout of MDR and other UDI-type regulations is causing more and more medical device companies to revisit their labeling processes to make sure they have a solution to maintain compliance across the extended supply chain. What got you through class II and class III device deadlines for FDA compliance may not be enough for new or emerging regulations in the EU, Middle East or within APAC countries.
What are the significant differences between the FDA’s requirements and those around the world? Can your labeling system quickly adapt to new language requirements? Do you have the visibility and control to manage global label variations beyond MDR labeling? Are you confident in producing a detailed and accurate audit report that meets the strict requirements of not just the FDA, but regulatory bodies in Russia, China and other regions?
These are just some of the question you’ll need to ask yourself. And a good place to start finding the answers is with a new white paper “Navigating Global UDI Requirements: How Enterprise Labeling Helps Sustain Compliance and Optimize the Supply Chain.” Co-written by Jay Crowley, VP of UDI Services and Solutions at USDM Life Sciences, the paper provides valuable insight to help you better understand medical device regulations and the inherent value of a robust, scalable and centralized labeling solution.
Take the first step toward true compliance with the EU medical device directive, and download the paper today. We encourage you to share it with other stakeholders within your organization because labeling should be everyone’s business.