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:
1) various business processes
2) complex business rules
3) different Global and Regional data elements
4) multiple exchange standards
As a manufacturer you also have to navigate multiple databases / 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 are 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., 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
Does that mean you need to collect them differently? 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.
Please contact us at 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 Commision MDR/IVDR deadline delays.
View top highlights from our most recent on-demand webinar: Global UDI Data Management – The New Paradigm
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.