We Won the Battle – But What About the War? The Next (BIG) Challenge for a Globally Harmonized UDI System

by Jay Crowley

As I mentioned in my last post, we were focused not only on developing a US UDI System, but maybe more importantly on a globally harmonized approach to UDI. There were a number of reasons for this; the first, and hopefully obvious one, is that a global UDI would allow all to have visibility across the global supply chain and be better able to share data among regulators about the safe and effective use of devices and, for example, be able to identify problems more quickly or address recalls across borders. Moreover, the device industry often labels and packages a single product for many (most/all) markets. And – unlike the pharma industry – we did not want (nor did we think we could afford) to have “national” or regional labels/packages (which would be required if there was national/regional device identifiers). Therefore, a “global” UDI – one that could be put on the labels and packages of devices and used anywhere in the world that UDI was required – was a paramount concern during the development of UDI.

Among the many activities undertaken to support this, including many bilateral discussions between FDA and other regulators, was the development of first the Global Harmonization Task Force (GHTF) and then the International Medical Device Regulators Forum (IMDRF) UDI guidance documents (see here and here). The goal of these documents, as stated in the Introduction, is to “… [provide] a framework for those regulatory authorities that intend to develop their UDI Systems that achieves a globally harmonized approach to the UDI.” To a VERY large extent, the US FDA UDI System regulation, as well as the recently published EU MDR/IVDR UDI System requirements, follow the guiding principles in these documents. Other regulators (e.g., Canada, Taiwan, Saudi Arabia) who have indicated a desire to develop their own UDI requirements have also indicated their willingness to follow these guidance documents.

So, from an identifier and label/package perspective, we can see that the goal of these guidance documents has largely been realized. With some (mostly) minor differences, we should be able to assign device identifiers to labels/packages and use that to meet global device identification requirements. The rules for assignment, changes, and construct are also largely aligned. What is NOT aligned, however, is the data that each country/regulator will want associated with each device identifier. Each country/regulator regulates devices differently and has different purposes for UDI, and therefore has specific (and different) national data needs. This means the new (and exponentially more complicated) challenge for the device industry is understating how to develop and maintain the ever-increasing (and different) data set associated with a single product distributed in multiple markets. More on master data management and UDI databases next time…

About the Author

Jay Crowley is the Vice President of the UDI 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.

About USDM Life Sciences

USDM Life Sciences is a global life science and healthcare services company, providing strategy and compliant technology solutions to regulated industries. If you work in Life Sciences or Healthcare, partnering with USDM Life Sciences makes it easy to accelerate innovation and maximize productivity. USDM Life Sciences only focuses on regulated industries and has built trusted partnerships with the most innovative technology companies in the world, and boast a staff of industry leading experts in the areas of technology and compliance.