UDI data management is continuously getting more complex. Not only do global markets have varying UDI requirements, but new markets are expected to come online in the coming months. Additionally, the mandatory application of EUDAMED will begin in January of 2026, meaning that MedTech manufacturers selling products in the European Union will have to submit their UDI information to EUDAMED.
Submitting UDI information to EUDAMED will require careful and thorough preparation to ensure that manufacturers have all of the required data attributes necessary to meet the EU’s requirements and that they have a strategy in place to organize, review, and submit all of their information.
MedTech regulatory affairs processes are largely manual and siloed, and UDI management is no different. Many teams are still managing their UDI data in complex spreadsheets. While the forthcoming mandatory EUDAMED requirements have prompted many manufacturers to start planning more comprehensive UDI strategies, managing a high volume of UDI data in spreadsheets is unsustainable long term.
Efficient and scalable UDI management requires deep expertise, collaboration, and full visibility into your products’ global regulatory activities that spreadsheets simply can’t match. Here are 5 reasons it’s time to move away from managing your UDI data in spreadsheets:
1. They’re setting you up for compliance risks
UDI management involves a high volume of data across different markets and regulator IT systems. Not only are the assembly and maintenance of those data in a spreadsheet prone to human error, but they don’t enable the regulatory expertise necessary to ensure that your requirements for each applicable market are up to date. Further, siloed spreadsheets aren’t connected to systems that help you unlock regulatory insights. The responsibility is yours to make sure your spreadsheet has current, accurate, and reliable information.
With cumbersome version history and change tracking (or lack thereof), spreadsheets also lack the traceability needed for audits, making it difficult and time-consuming for MedTech companies to effectively demonstrate compliance. This not only adds time to the audit, but opens your organization up for audit findings, financial penalties, product delays, and revenue loss.
2. They’re time-consuming and difficult to manage
When multiplying the markets you’re selling in by the number of products you’re selling, it’s easy to see how complex UDI spreadsheets can get. Since there’s no automation to ensure the attributes and data in your spreadsheet are up to date, it’s up to you to validate it periodically and research the updated requirements. If you do establish a process to validate that UDI data, this adds critical time for Medtech teams that are already tasked to execute faster with limited team members. If you do not periodically validate UDI data, you take on an increased risk of non-compliance.
Additionally, new market regulatory and IT requirements make managing UDI information even more difficult each time a new market is added. With several countries expected to mandate or enact new UDI requirements and systems over the next couple of years, the complexity is only going to grow with time.
3. They limit collaboration across your team
Multiple stakeholders working within the same spreadsheet can easily create confusion. Not only is it difficult to track changes, but there’s a likelihood of overwriting critical information. This can not only lead to the compliance risks mentioned above, but spreadsheets also impact your team’s ability to effectively collaborate. Team members often duplicate the spreadsheet and work off of different versions when there are limited controls in place to prevent this from happening.
On a strategic level, spreadsheets impact your team’s ability to share knowledge with one another. There’s no way to effectively share detailed notes and tasks, and there’s also limited functionality to track transmission status and troubleshoot transmission errors with your team.
4. They don’t provide full visibility into your products’ selling statuses
UDI spreadsheets are usually designed for one purpose, UDI data management. However, UDI is just one facet of obtaining market clearance for your product. The product must also be approved and registered in each respective market. Many manufacturers have multiple teams and spreadsheets to track regulatory activities where UDI responsibilities may lie outside of the regulatory team. This approach limits their ability to get full visibility into the status of their products and integrate this information with other relevant applications across the business. With regulatory information scattered and siloed, it’s easy to miss the connection between UDI data and upcoming expirations and renewals.
5. They don’t easily scale with your business and growing market requirements
As you create new products and bring existing ones into new markets, do you have a plan in place to help you scale effectively? The regulatory activities along with the expanding UDI requirements associated with new product introductions and market expansions are high enough, and spreadsheets simply can’t keep pace with business growth.
Moving your UDI management off spreadsheets is going to set you up for a successful, long-term UDI program. MedTech companies not only need to be aware of the forthcoming mandatory EUDAMED application timelines, but they also need a sustainable solution as additional UDI requirements come online. Finding a solution that’s built with the complexities of UDI data management in mind, automates time-consuming, manual processes, and offers complete visibility into all of your regulatory activities is going to help you ensure that your UDI program is compliant and scalable to meet your evolving business needs.
The Rimsys RIM platform allows you to manage your UDI program in a single-sourced, unified, and connected solution that enables you to track your UDI activities alongside your product registrations and selling status to give you confidence in your compliance. Additionally, Rimsys has a novel Universal UDI approach that captures common attributes across various market requirements to reduce administrative burden and help you submit your UDI information consistently and with ease.
Want to see how a purpose-built MedTech RIM solution can offer you a compliant, scalable, and comprehensive approach to UDI management? Request a demo to see Rimsys in action!
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