UDI Archives

What Global Manufacturers Need to Know About 2026 UDI Enforcement

Life Sciences, Medical Devices, Unique Device Identification

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

Life Sciences, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics, Unique Device Identification

Understand how the US government shutdown affects FDA operations and how LexisNexis supports healthcare readiness.

How a Government Shutdown Impacts the FDA and Healthcare Industry

Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics

A government shutdown forces the FDA to scale back operations, delaying new drug and device approvals and slowing healthcare innovation. Learn what continues, what pauses, and why prolonged disruptions matter for patients and providers

Swissmedic Launches UDI Module in swissdamed

Medical Device Safety and Quality, Medical Devices, Unique Device Identification

Swissmedic has launched the UDI module in swissdamed, marking a key step in Switzerland’s 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 TGA’s Phased Introduction: What Class III & IIb Device Sponsors Need to Know

Medical Devices, Unique Device Identification

Australia’s 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.

FHIR and the Future of Labeling

Drug & Biologic Product Submissions, Drug Label Research, Life Sciences, Medical Devices, Pharmaceutical and Cosmetics, Unique Device Identification

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

Medical Devices, Unique Device Identification

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

Drug Label Research, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics, Unique Device Identification

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).

FDA Updates Guidance on GUDID and GMDN Codes: What You Need to Know

Life Sciences, Medical Devices, Unique Device Identification

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

Company News, Life Sciences, Medical Devices, Unique Device Identification

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.

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Recent Blogs

What Global Manufacturers Need to Know About 2026 UDI Enforcement

30 Days Into the U.S. Government Shutdown: What It Means for the FDA and for You

How a Government Shutdown Impacts the FDA and Healthcare Industry

Swissmedic Launches UDI Module in swissdamed

Navigating the TGA’s Phased Introduction: What Class III & IIb Device Sponsors Need to Know

FHIR and the Future of Labeling

EUDAMED Rollout Delay: What It Means for Medical Device Manufacturers

Regulatory Survival Guide: FAQs Every Drug and Medical Device Manufacturer Should Know

FDA Updates Guidance on GUDID and GMDN Codes: What You Need to Know

EUDAMED Questions Answered; Navigating the Gradual Roll-Out of EUDAMED under MDR and IVDR Updates

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