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FHIR and the Future of Labeling
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Medical Devices
Recent Blogs
EUDAMED Rollout Delay: What It Means for Medical Device Manufacturers
The European Commission (EC) has missed a key milestone in the rollout of EUDAMED, the central database for medical devices in the EU. According to the previously published timeline, EUDAMED was expected to be declared “fully functional” by July 1, 2025. However, with that date now passed and no notice published in the Official Journal of the European Union (OJEU), the official timeline remains unmet.
Regulatory Survival Guide: FAQs Every Drug and Medical Device Manufacturer Should Know
Navigating drug and device regulations isn’t optional—it’s mission-critical. This Regulatory Survival Guide breaks down the complexities of global compliance, from FDA and EU MDR to Health Canada, UDI, and MoCRA. Whether you’re managing submissions or facing upcoming deadlines, use this FAQ to decode key terms, avoid costly risks, and stay ahead with expert-backed solutions like Compliance-as-a-Service (CaaS).
Reflecting on RAPS Euro Convergence 2025: Regulatory Innovation in Motion
Global supply chain shifts can jeopardize regulatory labeling. Learn how LexisNexis Reed Tech helps manufacturers stay compliant through agile, localized labeling solutions.
ESG NextGen Is Coming: Key Milestones, Blackout Dates & What You Need to Know
As part of ongoing enhancements to streamline data exchange and compliance processes, the ESG NextGen platform is preparing to go live this spring. We’re sharing a quick overview of the key milestones and what they mean for you especially as we approach the submission blackout period from April 12 to April 14, 2025.
FDA Updates Guidance on GUDID and GMDN Codes: What You Need to Know
Explore the FDA’s update on GUDID, focusing on the transition to GMDN Codes for device identification. Learn how to adapt to these changes efficiently.
EUDAMED Questions Answered; Navigating the Gradual Roll-Out of EUDAMED under MDR and IVDR Updates
Last week, the European Commission released a Q&A on practical aspects related to implementing the gradual roll-out of EUDAMED. In the following blog, we will cover highlights from the document and recommendations for the next steps.
Simplify Your Global Regulatory Compliance with a Singular UDI Vendor
As we continue to discuss optimal solutions to support the growth and compliance needs of industry, LexisNexis Reed Tech is committed to providing you with a single UDI vendor and platform.
LexisNexis Reed Tech and 1WorldSync Webinar Recap: Leveraging UDI and GDSN
On Tuesday, October 15, 2024, Reed Tech and 1WorldSync hosted a highly informative webinar led by Gary Saner, Senior Regulatory Principal at Reed Tech, and Scott Brown, Senior Director of Global Data Strategy at 1WorldSync. The webinar focused on how their continued alliance helps companies navigate Unique Device Identification (UDI) management and utilize the Global Data Synchronization Network (GDSN) to meet regulatory compliance requirements.