The Short Version
Every country that finalizes its Unique Device Identification (UDI) regulation stands up a new regulatory UDI database, each with its own business processes, business rules, data elements, and exchange standards. For device manufacturers marketing across regions, that means juggling multiple sources of truth. The practical answer isn't a separate dataset per regulator; it's a single global superset of data that captures every requirement once and adapts as new UDI regulations arrive.
Get Ready for Global UDI Regulations
As more countries release their UDI regulations, the implementation of their UDI databases will quickly follow. Are you ready?
IMDRF recently published an application guide for UDI Systems (IMDRF/UDI WG/N48 FINAL: 2019) to help standardize how UDI databases should be deployed. However, it does not give specific recommendations or implementation details on how to accomplish that standardization. Regulators will create new concepts and/or implementation details based on their regulation(s) and/or constraints based on existing information systems when they are implementing their regulatory UDI database. What we do know is that each of the UDI implementations will result in:
Four things every new UDI database introduces
- Various business processes — how data is collected, reviewed, and submitted differs by regulator.
- Complex business rules — cross-attribute validation and conditional requirements vary widely.
- Different global and regional data elements — the same device may require different attributes in different markets.
- Multiple exchange standards — the formats and protocols for submitting data are not uniform.
As a manufacturer, you also have to navigate multiple databases and source-of-truth systems to meet all of the UDI requirements. Don't get discouraged — USDM is here to help you develop a strategy for dealing with what may seem like an insurmountable challenge.
We believe that a single global superset of data will address many of the differences and similarities in data requirements.
As the preliminary EUDAMED implementation specs become available, several of the data elements have been implemented differently than in the GUDID. We have seen differences in how the data will be collected — including, but not limited to:
- different valid values for data elements (e.g., differences in the device type nomenclature, critical warnings, etc.)
- different required data based on regulations or type of medical device (e.g., special device types, or classes of devices)
- variance in whether a data element is required, optional, or conditionally optional; different business rules (e.g., cross-attribute value validation)
- different data types (e.g., a coded value in one region may be collected as a text value in others)
- variation in the number of values that may be submitted (e.g., one value allowed versus many)
- differences in what triggers a new UDI-DI, which will cause larger issues with medical devices that are marketed across regions
- the interface to other regulatory databases and the implications of keeping data consistent and up to date between the various business processes that are supported by each one
Do You Need to Collect Data Differently for Every Region?
Not necessarily. USDM has crafted a strategy to help manufacturers manage the single global superset of data. We have identified the commonalities and unraveled the differences in the known datasets to create a superset of data elements for manufacturers to manage. We believe it will support the current regulatory agency UDI submission requirements in addition to being extensible to evolving UDI regulations in other countries.
Why the superset approach works: Managing UDI data once — rather than rebuilding it for each regulator — keeps your records consistent across markets and shrinks the rework when the next regulatory UDI database goes live. Treating UDI as a governed, high-integrity data asset is foundational, which is why strong data integrity in life sciences practices matter as much as the database itself.
Build UDI on a Compliant, Connected Foundation
UDI submission spans validated systems, master data, and regulatory recordkeeping — all of which sit inside your broader quality and compliance landscape. Aligning UDI work with established 21 CFR Part 11 compliance expectations for electronic records, and keeping those systems audit-ready through Cloud Assurance, means your UDI data stays trustworthy from collection through submission. As manufacturers adopt newer tools to wrangle multi-region data, applying disciplined AI governance and compliance keeps innovation inside the lines.
Please contact USDM if you are interested in learning more about our single global superset approach, or want more information on how we can help you manage your medical device portfolio in the context of your organization — i.e., going beyond the global UDI requirements.
*This blog was written prior to the European Commission MDR/IVDR deadline delays.
View top highlights from our most recent on-demand webinar: Global UDI Data Management — The New Paradigm
FAQ: Global UDI Regulations and Databases
What is a regulatory UDI database?
A regulatory UDI database is the system a health authority uses to collect and store Unique Device Identification data for medical devices. Examples referenced in this article include the FDA's GUDID and the EU's EUDAMED. Each one is deployed by its regulator with its own business processes, business rules, data elements, and exchange standards.
Why can't I use the same UDI data for every country?
Because regulators implement UDI differently. We have seen variation in valid values, required versus optional versus conditionally optional fields, data types, the number of values allowed, and even what triggers a new UDI-DI. A device marketed across regions can face conflicting requirements in each database.
What is a "single global superset of data"?
It is USDM's strategy of identifying the commonalities and unraveling the differences across known UDI datasets to define one superset of data elements for manufacturers to manage. It is designed to support current regulatory UDI submission requirements while remaining extensible to evolving UDI regulations in other countries — so you manage UDI data once instead of rebuilding it per regulator.
How does IMDRF fit in?
IMDRF published an application guide for UDI Systems (IMDRF/UDI WG/N48 FINAL: 2019) to help standardize how UDI databases should be deployed. It does not, however, provide the specific recommendations or implementation details needed to accomplish that standardization, so regulators still introduce their own concepts and constraints.
Why does data integrity matter so much for UDI?
UDI records flow across validated systems and multiple regulatory databases, and they must stay consistent and current between every business process that depends on them. Treating UDI as a governed, high-integrity data asset reduces inconsistencies and the rework triggered each time a new regulatory UDI database goes live.
Ready to Get Ahead of the Next UDI Database?
Whether you are preparing for EUDAMED, refining your GUDID submissions, or planning for the next country to publish its UDI regulation, USDM can help you build a single, extensible strategy. Contact us to learn more about the global superset approach and managing your medical device portfolio.
Learn More:
UDI Strategy and Implementation
EU MDR / IVDR Strategy and Implementation
About the Author
Marti Velezis has over twenty years of professional experience in standards development and implementation, project management, enterprise architecture and business analysis. She serves as a Unique Device Identification technical expert for device manufacturers and international regulatory agencies and authorities. She focuses her work on technical support for UDI requirements development and analysis, process improvement, systems development and UDI submission support.