UDI & Medical Device Data Management Solutions

UDI & Device Data ManagementCentralize UDI and device data
Support UDI submissions, lifecycle changes, and data syndication across health authorities and trading partners.
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LexisNexis Life Sciences simplifies global UDI management across the product lifecycle—from data collection and submission to ongoing updates and compliance. Our technology and regulatory expertise help ensure your device data remains compliant across EUDAMED, AusUDID, Swissdamed, and other health authority databases, reducing burden and risk.

Source dataCreate one source of truth

LexisNexis Life Sciences centralizes UDI submission data in a single, flexible solution and stores product data in a secure cloud repository. That helps teams keep master data current, accurate, and comprehensive while assigning roles and permissions for corporate users and in-country legal representatives.

Global channelsScale across authorities

LexisNexis Life Sciences manages UDI data throughout the product lifecycle and supports current or staged channels for US FDA, China NMPA, South Korea MFDS, EU EUDAMED, and Australia UDID. Teams can centralize submissions by selectable channel as they enter a market.

Data sharingKeep data aligned

LexisNexis Life Sciences helps teams use the same product data set for regulatory submission and downstream distribution. Global Data Synchronization Network (GDSN) syndication and centralized version control support sharing with customers, trading partners, Group Purchasing Organizations, hospital networks, and UK NHS eProcurement.

CapabilitiesCore UDI service tasks

Here’s a practical look at the main jobs LexisNexis Life Sciences can take on, from preparing UDI data to keeping records aligned across authorities and trading partners.

Import and transform data

Import UDI data files and extract, transform, and load records into the solution. This helps teams prepare data for submission and ongoing management.

Validate and submit UDI

Validate UDI data values against FDA and business rules, then submit SPL-UDI messages to FDA. LexisNexis Life Sciences also processes and stores FDA acknowledgement messages.

Guided lifecycle support

Guided support can collect and validate UDI data, build HL7 Structured Product Labeling (SPL) records, and perform ongoing record lifecycle management. Training is available through 1:1 and group sessions.

Centralize product data

Store product data in a secure cloud repository, keep master data current, and assign roles and permissions for corporate users and in-country legal representatives. This supports a shared view of UDI data.

Audit and compliance controls

View audit trails and version history, retain regulatory authority acknowledgements, and manage version control for role-based permissions. The system also supports 21 CFR Part 11 and EU Annex 11 technical requirements.

Global data syndication

Share medical device product data with trading partners through the Global Data Synchronization Network (GDSN) and distribute accurate UDI data to EUDAMED for MDR/IVDR. It also supports testing UDI product data for future global health authorities.

Data Security, Privacy, and Governance

Security and privacy you can count on

Privacy by design

LexisNexis protects customer data wherever it is stored, sent, or accessed. We apply privacy by design principles at every stage of development to ensure security and compliance are built in from the start. Our advanced encryption and rigorous compliance protect your sensitive information.

Strict security protocols

LexisNexis systems meet the highest standards for information security. We partner with trusted, enterprise-grade cloud providers, continuously monitor and improve our infrastructure,

What’s Changing in 2026

Global UDI Requirements Are Expanding

Health authorities around the world are mandating Unique Device Identification (UDI) requirements and 2026 marks a critical milestone year. For medical device manufacturers operating across multiple markets, these compliance dates introduce new data submission, maintenance, and lifecycle management obligations.

Managing UDI in one region is complex. Managing it across multiple regions requires a coordinated global strategy.

EU (EUDAMED)

Mandatory use of four modules including UDI/Device starts May 28, 2026

Australia (AusUDID)

First phased deadline for Class III & IIb medical devices is July 1, 2026

Switzerland (swissdamed)

Mandatory use of the Product Module begins July 1, 2026

Who is UDI & Device Data Management for?

If you’re a medical device manufacturer, device labeler, or regulatory or compliance staff managing UDI data across multiple health authority channels, this offering is built to centralize product data and support submission, maintenance, and syndication. LexisNexis Life Sciences also supports shared access for corporate users, local affiliates, and in-country legal representatives.

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  • Medical device manufacturers
  • Device labelers
  • Regulatory staff
  • Compliance staff
  • Local affiliates
  • In-country legal representatives
Frequently asked questions

It is a cloud-based service for centralizing medical device Unique Device Identification (UDI) data, managing submissions, and sharing product data. LexisNexis Life Sciences also supports product data lifecycle management for regulatory authorities, customers, and trading partners.

It is designed for medical device manufacturers, device labelers, and regulatory or compliance staff managing UDI data. LexisNexis Life Sciences also supports corporate users, local affiliates, and in-country legal representatives through role-based access.

LexisNexis Life Sciences can import data files, extract, transform, and load records, validate values, submit SPL-UDI messages to FDA, and process acknowledgement messages. Guided support can also collect data, build HL7 Structured Product Labeling (SPL) records, manage ongoing lifecycle changes, and provide training.

It centralizes UDI submissions by selectable channel and supports current or staged channels for US FDA, China NMPA, South Korea MFDS, EU EUDAMED, and Australia UDID. It also supports MDR/IVDR distribution to EUDAMED and testing for future global health authorities.

Yes. Global Data Synchronization Network (GDSN) syndication supports sharing medical device product data with trading partners and helps organizations meet requirements from UK NHS eProcurement, Group Purchasing Organizations, and hospital networks.

The solution includes audit trails, version history, role-based permissions, and retention of regulatory authority acknowledgements. It also supports 21 CFR Part 11 and EU Annex 11 technical requirements in a fully verified system.

Talk to a Life Sciences Regulatory Professional Today

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Reed Tech is now LexisNexis Life Sciences Solutions

While the Reed Tech name is being retired, the business has long operated as part of LexisNexis. Customers will continue to work with the same regulatory experts, services, and solutions—now unified within LexisNexis Life Sciences to reflect the broader capabilities and global resources of LexisNexis.