If your company is selling medical devices in the European Union, you’re likely thinking about EUDAMED. If you’re not, it's time to start. Come January 2026, medical device manufacturers will be required to submit their UDI data to EUDAMED. EUDAMED’s data requirements and interconnectivity are complex. Not only is it easy to underestimate the time it will take to organize and verify UDI data, but many manufacturers are still using manual processes such as spreadsheets or internally built systems to manage this information. And with a number of organizations treating UDI data management and submission as an IT or supply chain process, some RA teams don’t even know where their UDI data is.

Getting your UDI data EUDAMED ready for submission by January 2026 is going to take some time, but there is a tremendous opportunity amidst the extensive preparation. With a little bit of foresight, RA teams can position the data output of their EUDAMED compliance project as the foundation for a global UDI program. Here are some reasons why using EUDAMED as the primary building block for a global UDI strategy will enable long-term success:

The product data needed for EUDAMED can be applied to current and future global UDI requirements

With many required data attributes and Basic UDI family groupings, establishing EUDAMED compliance for UDI is going to take some careful planning, detailed organization of current data, and careful consideration of your regulatory strategy for the European market.  Many manufacturers need to start with the basics: locating current UDI data to understand how it is currently managed and transmitted to the respective regulatory bodies. This process is also going to require an assessment of your UDI data. Do you have information populated for all of the required attributes?Is this information current and accurate? Finding answers to these questions is going to take thoughtful collaboration among all stakeholders, but it’s also going to set your organization up with a solid data foundation that will help you meet additional market requirements.

It’s going to require an audit of your people, processes, and systems

Industry is focused on establishing UDI data in EUDAMED to align with current requirements for timing but transmitting your UDI interaction with EUDAMED is not a one-time process as it may be currently treated for other regulators. New devices, device changes, UDI data updates, and commercial availability may require EUDAMED updates or establishing new UDI profiles altogether.  Are your current processes able to support you long-term? Manual processes are going to make it nearly impossible to keep pace and compliance, and internally built systems are going to require regular validation and subject matter expertise to keep up with evolving requirements and EUDAMED version updates. Taking the time to make sure you have the proper expertise and systems to maintain EUDAMED compliance will more easily allow you to scale your UDI management as your business grows and the regulatory landscape evolves.

The risks of non-compliance are too steep to ignore

Those who fail to submit UDI data to EUDAMED in line with the required timelines are at risk of audit findings, financial penalties, product delays, and worst of all, having to remove products from the market. Not only does product removal have lasting productivity, competitive, and economic impacts on the manufacturer, but it also decreases the availability of life-changing medical devices to end users. These risks are simply too significant to ignore and necessitate a comprehensive global compliance strategy that can meet the needs for EUDAMED and additional countries as global regulations change.

Additional regulators are establishing UDI requirements and big data technologies

As the value of UDI is recognized, More global markets are adopting UDI requirements to enhance the traceability of their devices and improve patient safety. For instance, Australia has established UDI requirements with mandatory compliance for data submission expected in the summer of 2025. Additionally, Rimsys expects the competent authorities from Switzerland and the United Kingdom to adopt their own UDI requirements following their exit from the European Union. Even though each regulator has varying requirements to some degree, organizing product data to meet EUDAMED’s robust set of data attributes and requirements will put you in a position to more easily meet additional global UDI requirements.

How Rimsys supports a global UDI strategy‍

Both the regulatory and technology requirements for UDI continue to grow in complexity. Rimsys has an integrated, automated UDI solution that provides medical device manufacturers the ability to manage their UDI data alongside their regulatory activities for total visibility and control.  

Not only does Rimsys have the expertise necessary to help MedTech manufacturers navigate UDI data and transmission to EUDAMED for January 2026, but we're also dedicated to supporting MedTech companies with solutions and strategies that go beyond EUDAMED compliance to support a scalable and efficient global UDI program to meet the needs of evolving regulatory requirements. Rimsys provides MedTech manufacturers with a single-sourced UDI solution that allows them to manage their UDI data and status alongside regulatory activities.

Our novel Universal UDI® approach centrally stores common data attributes across global markets for simple management, reduced compliance risk, and increased efficiency. Using data established in Rimsys for EUDAMED as a baseline, we’re enabling MedTech companies to more easily meet additional global UDI requirements in a unified RIM solution that applies these common attributes between various market requirements (with more coming soon!):

Ready to increase your team’s efficiency and compliance with integrated and automated UDI management to support your long-term goals? Request a custom Rimsys UDI demo here!

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