UDI and Product Data
This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices to manage medical device product data for established and newly formed Health Authority UDI mandates around the world.
Recent Blogs
What Global Manufacturers Need to Know About 2026 UDI Enforcement
In 2026, medical device manufacturers face mandatory UDI enforcement across the European Union (EUDAMED), Australia (AusUDID), and Switzerland (Swissdamed). Regulators are shifting from system rollout to active compliance oversight, requiring continuous data maintenance, alignment between labeling and database records, and audit-ready transparency. Global manufacturers must implement centralized UDI governance and lifecycle management strategies to reduce regulatory risk and maintain market access.
30 Days Into the U.S. Government Shutdown: What It Means for the FDA and for You
Understand how the US government shutdown affects FDA operations and how LexisNexis supports healthcare readiness.
Swissmedic Launches UDI Module in swissdamed
Swissmedic has launched the UDI module in swissdamed, marking a key step in Switzerlandās medical device regulation. Voluntary submissions begin in August 2025, with mandatory registration starting July 2026. The system aligns with EUDAMED standards to enhance traceability, compliance, and post-market surveillance.
Navigating the TGAās Phased Introduction: What Class III & IIb Device Sponsors Need to Know
Australiaās Therapeutic Goods Administration (TGA) is taking a phased approach to regulatory compliance, prioritizing higher-risk medical devices first and gradually expanding requirements to lower-risk categories in the coming years. This structured rollout is designed to manage the complexity of implementation while ensuring that patients and healthcare systems benefit from stronger safeguards at the earliest possible stage.
Pharmaceutical Industry Top Innovators
Explore the key Pharmaceutical Innovators revealed in the latest Innovation Momentum report and their impact on the industry.
FHIR and the Future of Labeling
Learn how manufacturers can adopt FHIR to modernize labeling, enhance traceability, and meet evolving regulatory expectations.
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 āfully functionalā 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.Ā
Regulatory Survival Guide: FAQs Every Drug and Medical Device Manufacturer Should Know
Navigating drug and device regulations isn’t optionalāit’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).
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.