Quick Summary
As regulators around the world stand up their own UDI and UDI-like systems, device manufacturers can no longer treat device data as a regulatory checkbox. Each new market adds device identification requirements layered with national concerns such as counterfeit prevention, traceability, and reimbursement. Meeting these obligations sustainably requires a single, cross-organization, data-centric framework so that regulatory, quality, clinical, supply chain, and commercial teams all work from the same trusted device information across the entire product lifecycle.
The melding of regulatory, commercial, and patient-safety information needs
To promote global harmonization, the International Medical Device Regulators Forum (IMDRF) set out basic 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 country or regulator-specific UDI or UDI-like systems, they are not only trying to address device identification, they also want to support the resolution of particular national or local concerns (e.g., counterfeits, traceability, cost-control/reimbursement).
Navigating Complex Challenges for Device Manufacturers
These new regulatory, commercial, and patient-safety use cases create novel and complex challenges for device manufacturers, who now must establish and maintain robust global systems and processes that allow them to develop, maintain, and submit the ever-growing (and ever-changing) information to these various systems and stakeholders. In ways not seen before, manufacturers must be able to create, maintain, and associate a broad set of global device attribute information, with real-world clinical information to support its indications, continuous receipt and analysis of quality, performance, and safety data, as well as information related to its distribution and costs.
The data that feeds a UDI submission is the same data that drives recall management, complaint handling, and post-market surveillance. Treating it as a clean, governed, lifecycle asset — not a one-time submission artifact — is what separates a sustainable program from a perpetual fire drill. Strong data integrity practices are the foundation that makes every downstream submission trustworthy.
Device manufacturers must work together with other stakeholders to help guide and manage this growing need for information. Understanding what is happening globally – and why – will help prepare manufacturers to develop and support these global initiatives. This will also require manufacturers to upend their traditional siloed approach to data and information where regulatory, quality, clinical, supply chain, marketing, and product owners all created and maintained their data separately. Importantly, in this future, every part of the organization must have access to and use the same information about a device, over the device’s entire lifecycle, across the entire organization, and in any and all external communications about that device.
Every part of the organization must have access to and use the same information about a device — over the device’s entire lifecycle, across the entire organization, and in every external communication about that device.
Building a Cross-Organization, Data-Centric Framework
In order to develop sustainable structures to manage the multitude and magnitude of regulatory, commercial, and patient-safety information needs, manufacturers must develop and implement an over-arching, cross-organization data-centric framework for how they will manage the growing data imperative and interact with healthcare providers, researchers, patients, purchasers, insurers, and regulators to improve device safety and effectiveness, all while reducing risks and associated costs.
Pillars of a Sustainable Global UDI Data Program
- Single source of device truth — One governed set of device attributes shared by regulatory, quality, clinical, supply chain, and commercial teams, rather than siloed copies maintained independently.
- Lifecycle data stewardship — Device information that is created, maintained, and associated across the full product lifecycle, with the data integrity controls regulators expect.
- System and process readiness — Aligned PLM, ERP, EPCIS, labeling, printing, vision inspection, and warehouse/inventory systems with reliable interfaces to GUDID and other registries.
- Validated, compliant change management — Controlled changes to identification, labels, and packaging, supported by computer software assurance and risk-based validation so updates stay audit-ready.
- Continuous compliance posture — Ongoing monitoring as requirements shift across markets, reinforced by USDM Cloud Assurance to keep validated systems in a state of control.
Watch the related webinar segment discussing the global UDI landscape and how to harness your data for medical device identification.
How USDM Helps Manufacturers Meet the Global UDI Imperative
USDM is the industry leader in compliance and technology and is creating an innovative, future-proof solution to help you manage these upcoming changes for UDI submissions globally. We look forward to continuing to help device manufacturers improve their UDI data management strategies.
USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM's assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.
FAQ: Global Medical Device Data and UDI
What is UDI and why does it matter for medical device manufacturers?
Unique Device Identification (UDI) is a system for identifying medical devices through their distribution and use. It matters because regulators, purchasers, and other stakeholders rely on consistent device data to address device identification along with concerns such as counterfeits, traceability, and cost-control or reimbursement.
Why are global UDI requirements becoming more complex?
The IMDRF set out basic UDI requirements and recommended shared data elements to promote harmonization. As individual countries and regulators stand up their own UDI or UDI-like systems, they add national and local requirements on top of the shared elements, so manufacturers must develop, maintain, and submit ever-growing and ever-changing information to multiple systems and stakeholders.
Why is breaking down data silos so important?
Traditionally, regulatory, quality, clinical, supply chain, marketing, and product teams created and maintained device data separately. To meet global UDI obligations sustainably, every part of the organization must have access to and use the same device information over the device’s entire lifecycle and in all external communications about that device.
What systems are affected by UDI changes?
UDI implementation can touch labels and packaging, product identification, PLM, ERP, and EPCIS, as well as printing, vision inspection, and warehouse or inventory management systems, along with the interfaces that connect them to registries such as the GUDID.
How does USDM help manufacturers manage their UDI data?
USDM helps device manufacturers assess their products and target markets, determine an implementation strategy, and execute the changes and enhancements necessary to meet UDI regulations — spanning labeling, packaging, identification changes, connected systems, and submission interfaces.
Ready to build a sustainable global UDI data strategy? USDM helps device manufacturers assess, plan, and execute the data and system changes that global UDI regulations demand. Contact our team to get started.
About the Author
Jay Crowley is the Vice President of the Unique Device Identification Services and Solutions at USDM Life Sciences. Jay was most recently 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 FDA’s Unique Device Identification system.
At USDM Life Sciences, Jay focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry. Jay held a variety of positions over his 26 years at FDA, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety and adverse event reporting. Jay also worked in the Office of the Commissioner of FDA, and the Office of Compliance at FDA.