On-Demand Webinar
To promote global harmonization, the International Medical Device Regulators Forum (IMDRF) set out basic Unique Device Identification (UDI) requirements, including recommended "shared" data elements, in their guidance document Unique Device Identification (UDI) of Medical Devices. However, as regulators, purchasers, and other global stakeholders begin to develop and implement UDI (or UDI-like) systems, they are also trying to address device identification initiatives and support national or local concerns—such as counterfeits, traceability, and cost-control/reimbursement.
These new use cases create challenges for device manufacturers, who must establish and maintain robust systems and processes that allow them to submit ever-growing (and ever-changing) product information to various systems and stakeholders.
What You'll Learn
- How regulatory, commercial, and patient-safety information requirements are changing as UDI and UDI-like systems expand worldwide.
- Why national and local use cases—counterfeits, traceability, and cost-control/reimbursement—are layering new product data demands on top of IMDRF's shared data elements.
- Practical ways device manufacturers can address these growing and shifting product-information needs.
- How to think locally, nationally, and globally at the same time to minimize the overall compliance burden.
- How registry connections such as EUDAMED relate to GDSN data exchange between manufacturers, wholesalers, GPOs, and hospitals.
What This Discussion Covers
- Changes in regulatory, commercial, and patient-safety information requirements
- Ways in which device manufacturers can address these growing needs
- How to think locally, nationally, and globally to minimize compliance burdens
Why this matters: UDI is no longer a single submission to a single regulator—it is an ongoing, multi-system product data obligation that touches regulatory affairs, commercial operations, and patient safety at once. Treating UDI as a recurring data-management discipline rather than a one-time project is what keeps manufacturers ahead of new and changing requirements. USDM helps life sciences companies build the validated systems and data integrity practices that make product information trustworthy and submission-ready across every market they serve.
About the Presenters
Jay Crowley, Vice President of Unique Device Identification Solutions, USDM Life Sciences
Jay was Senior Advisor for Patient Safety in the Food and Drug Administration's Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA's Unique Device Identification system.
Lionel Tussau, Director, Strategic Industries, atrify
Lionel Tussau is leading healthcare initiatives at the product content solution provider atrify, both for connections with Regulatory UDI databases (such as EUDAMED) and GDSN projects between manufacturers, wholesalers, GPOs, and hospitals. He also represents atrify in MedTech Europe, as chairman of the EUDAMED IT Expert group, and is an observer in the EUDAMED MDCG working group. Before joining atrify more than ten years ago, Lionel spent 16 years in the FMCG industry, managing collaborative supply chain projects and implementation of GS1 standards.
FAQ: Evolving Global UDI Product Data Requirements
What is UDI and why did IMDRF define shared data elements?
UDI—Unique Device Identification—is a system for identifying medical devices through their distribution and use. To promote global harmonization, the International Medical Device Regulators Forum (IMDRF) set out basic UDI requirements, including recommended "shared" data elements, in its guidance document Unique Device Identification (UDI) of Medical Devices, so that manufacturers and regulators can work from a common foundation.
Why is UDI getting harder for device manufacturers if there is a shared framework?
As regulators, purchasers, and other global stakeholders develop and implement their own UDI (or UDI-like) systems, they layer national and local concerns—such as counterfeits, traceability, and cost-control/reimbursement—on top of the shared elements. These new use cases mean manufacturers must submit ever-growing and ever-changing product information to many different systems and stakeholders.
How do EUDAMED and GDSN fit together?
EUDAMED is an example of a regulatory UDI database, while GDSN supports product data exchange between manufacturers, wholesalers, GPOs, and hospitals. The webinar discusses how connections to regulatory UDI databases and GDSN-based commercial data flows relate to one another as part of a broader product information strategy built on GS1 standards.
How can manufacturers reduce their UDI compliance burden?
The session covers ways device manufacturers can address growing data needs and how to think locally, nationally, and globally at the same time so that the same product information can serve multiple requirements—minimizing duplicated effort and overall compliance burden.
What role do validated systems and data integrity play in UDI?
Because UDI is an ongoing, multi-system data obligation, the underlying systems must be reliable and the data trustworthy. Strong data integrity and 21 CFR Part 11 practices help ensure that the product information manufacturers submit is accurate, complete, and defensible across markets.
Watch the on-demand webinar to hear Jay Crowley and Lionel Tussau walk through how UDI requirements are evolving worldwide and what device manufacturers can do to stay ahead. To talk through your own UDI data strategy with USDM, contact us.