EUDAMED 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.

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.

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.

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.

Simplify Your Global Regulatory Compliance with a Singular UDI Vendor

Medical Devices, Unique Device Identification

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

Global Data Synchronization Network, Medical Devices, Unique Device Identification

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.

EUDAMED-Now or Later?

Medical Devices

With the EUDAMED go-live date rescheduled multiple times, manufacturers face conflicting strategies of when to make UDI/Device registration submissions to EUDAMED.

LexisNexis® Reed Tech expands MedTech Regulatory Compliance Solutions and Services for medical device companies

Company News, Medical Devices

LexisNexis® Reed Tech, a leading provider of regulatory submissions, data management, and analytics solutions for the life sciences industry, is expanding its services portfolio to a varied suite of regulatory compliance solutions and services to support medical device manufacturers, distributors, and related operations.

Expert Insights on the EU Proposed Legislation EUDAMED Rollout-Approved

Company News, Drug & Biologic Product Submissions, Medical Devices, Unique Device Identification

On January 23, 2024, the European Commission proposed a legislative amendment to address two major issues in the EU Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).

EC Proposal Updates on IVDR Transition & EUDAMED Rollout

Medical Devices, Unique Device Identification

Quick Insights from our experts on the EC Proposal concerning the IVDR transition and proposed MDR/IVDR amendment, possibly affecting the EUDAMED rollout. These are short segments created from our latest presentation, prepared exclusively for UDI customers.

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Recent Blogs

What Global Manufacturers Need to Know About 2026 UDI Enforcement

Swissmedic Launches UDI Module in swissdamed

EUDAMED Rollout Delay: What It Means for Medical Device Manufacturers

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

Simplify Your Global Regulatory Compliance with a Singular UDI Vendor

LexisNexis Reed Tech and 1WorldSync Webinar Recap: Leveraging UDI and GDSN

EUDAMED-Now or Later?

LexisNexis® Reed Tech expands MedTech Regulatory Compliance Solutions and Services for medical device companies

Expert Insights on the EU Proposed Legislation EUDAMED Rollout-Approved

EC Proposal Updates on IVDR Transition & EUDAMED Rollout

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