The medical device industry is entering a regulatory environment where UDI compliance is a requirement beyond the US market. EU compliance is a few short years away, and while many organizations are familiar with steps to address UDI compliance, EU MDR has added significant complexity to the process. Master data has become a particularly relevant issue teams must address as they develop their compliance strategy.
Organizations typically manage UDI master data submissions using dedicated databases or enhancements to their enterprise master data systems. Each approach has its merits and drawbacks, but teams must actively develop plans based on incomplete draft requirements as the EUDAMED technical specifications are developed. UDI teams should move forward with this phase now rather than delay them until final requirements are available. This is especially important since Basic UDI-DIs should be associated with technical files. Having a repository for these identifiers, along with a means of managing the relationship between these Basic UDI-DIs and product DIs (GTINs), is critical as technical files are prepared for EU MDR. Establishing this relationship and defining other UDI-relevant attributes now presents an opportunity to develop this information more efficiently, eliminating the need to circle-back and update these technical files once database updates are implemented.
This approach presents some, mostly technical, risks of having to revise data element specifications and business rules once the EUDAMED technical specifications have been published. However, these risks are overcome by eliminating the need to review and update technical files.
About the Author
Michael is a team lead with the USDM Unique Device Identification practice, where he assists clients with UDI compliance programs, as well as a broad range of labeling, supply chain and master data challenges. He is a PMP-certified project manager and brings broad experience in medical device manufacturing, supply chain, order-to-cash and labeling standards. Mike holds a MBA in Operations Management from Drexel University and a BS in mechanical engineering from Rensselaer Polytechnic Institute.
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.