UDI Labeling Going Global
Just as medical device companies have achieved a comfort level with their labeling programs to ensure compliance with the FDA's Unique Device Identification (UDI) system, along comes Europe's version of UDI with a few different wrinkles. Even if you do just a minimal amount of business in this region, you need to be aware of the requirements and associated deadlines. That's why events like the UDI Conference in Baltimore, MD, next week are so important.
At last year's UDI conference, it seemed like the manufacturers, contract manufacturers and distributors we spoke with were further along with their UDI programs than the previous year. It was just a matter of fine tuning processes and improving efficiencies across their organization. Now with the recent publishing of new requirements in Europe, medical device companies must gear up again and manage some of the nuances that will help sustain global compliance.
The 2018 event will offer multiple, helpful sessions on regulatory fundamentals, global harmonization and an International Medical Device Regulators Forum (IMDRF) Attendees can choose between two concurrent tracks: "UDI Basics" and "Global UDI-Related Activity." The agenda is designed to be your regulatory guide, depending on where you are with your readiness, and will furnish you with the necessary topics and expert speakers to help you with UDI compliance.
If you're well ahead with the FDA's UDI requirement and want to better prepare for global regulations, you'll want to attend two sessions featuring industry expert Jay Crowley from USDM Life Sciences. Jay will provide an "Update on EU UDI System" and another track on "The EU MDR & IVDR Regulations: Effective Tactics & Strategies for Implementation," both of which will take place the morning of April 24th. As a strategic partner of Loftware, USDM Life Sciences—and Jay Crowley in particular—have worked with us on several thought leadership webinars, papers and surveys to help organizations navigate regulatory compliance while driving supply chain efficiency.
If you're heading to the conference, be sure to stop by Loftware's booth #10 to learn how Enterprise Labeling Solutions help companies adhere to UDI regulations, enhance traceability and reduce costs. While there, we invite you to join us at the USDM cocktail reception on Tuesday, April 24 from 5-7 at the Executive Suite at the Renaissance Baltimore Harborplace Hotel (register here).
In the meantime, we invite you to view our new report Regulatory Labeling Guide: 6 Best Practices to Sustain Compliance. The paper outlines common obstacles for regulatory labeling and provides 6 best practices organizations can implement to overcome these challenges. See you next week!