As I mentioned in my last post, I believe our goal of a “globally harmonized” approach to UDI appears to be on a path to relative success. Though not our intent in developing the Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF) UDI guidance documents, the majority of the EU Medical Device Regulations (MDR)/In Vitro Diagnostic Regulations (IVDR) UDI System requirements are literally copied and pasted from the IMDRF guidance document (please send an email to email@example.com if you would like a copy of the comparison). More importantly, other regulators have also committed to following the principles in these guidance documents. So maybe a word of caution to other regulators: these documents provide “guiding principles” that need to be incorporated into the appropriate regulatory framework. They are not intended to be out-of-the-box regulatory text.
The one area where we do see (necessary) diversion is in the UDI Databases. Each country or regulator manages the regulation of devices differently – and, in many cases, has different (or additional) purposes for UDI. For example, in the US, we are focused on identifying a device through distribution and use to facilitate more accurate adverse event reporting; reducing medical errors; documenting device use in, for example, electronic health records; improving post market surveillance; better recall management; and helping to address counterfeiting and diversion. The EU system is also intended, for example, to “…improve purchasing, waste disposal policies and stock-management by health institutions.” Those needs necessarily require certain (additional) data attributes to be provided.
To “borrow” a phrase from my friend Dennis Black, what we are seeing now is an exponential growth in the data (the “attribute rodeo”) that is required for each UDI Database. For example, although there are 17 data attributes that appear to be common between the Global UDI Database (GUDID) and the European Database of Medical Devices (Eudamed), close to half may need to be provided differently to Eudamed than they are to GUDID. Eudamed also has 10 additional data attributes that are not in GUDID (GUDID has about 15 that are not in Eudamed). Moreover, there are likely to be at least 6 data attributes in Eudamed that will need to be translated (and submitted) into the 24 official languages of the EU. And all that data will need to be created, stored, submitted, updated and managed over the life-cycle of the device. You do the math…
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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.