Rimsys recently hosted a webinar with RAPS titled “Planning Your Enterprise’s UDI Strategy for EUDAMED and Beyond.” During the session, our experts, Adam Price, Director of Regulatory and Technical Programs, and James Gianoutsos, Founder and CEO, provided best practices to help MedTech companies navigate the complexities of Unique Device Identification (UDI) compliance. The session covered key topics such as comparing US and EU UDI regulations, preparing for the January 2026 mandatory EUDAMED submission date, and using EUDAMED as a foundation for a global UDI strategy that can scale as additional markets adopt UDI requirements.
Here are some of the key topics we discussed to help Medtech teams prepare their strategy:
1. The importance of UDI to regulatory affairs teams
UDI is a globally unique identifier for medical devices that helps improve traceability, manage adverse event reporting, and ensure compliance with regulatory requirements. Regulatory affairs teams play a critical role in both establishing and maintaining UDI data to meet submission timelines and market placement requirements.
Responsibility for UDI management can vary between organizations, with some MedTech companies assigning the responsibility to IT or supply chain teams. When we asked our audience who is responsible for UDI management at their company, 80% of respondents said that it was their regulatory affairs team, emphasizing UDI’s crucial role in market placement.
2. Comparing US and EU UDI Requirements
FDA GUDID requirements have been in place since 2014. As such, some MedTech teams may plan to use their GUDID submission strategy as a baseline for the development of their EUDAMED submission strategy. While the US FDA’s GUDID system has standardized requirements, the EU’s EUDAMED is more complex due to additional data fields, language-specific entries, and the use of the EMDN nomenclature instead of GMDN. EUDAMED also introduces the Basic UDI-DI, which connects related devices within family groupings and links different EUDAMED modules. Companies must adapt their UDI strategies to account for these variations.
“Unlike the standardized US GUDID, the EU’s EUDAMED is more complex, featuring multiple device categories, language-specific data, and the EMDN nomenclature.” - Adam Price
3. The Interconnectivity of EUDAMED
EUDAMED consists of multiple interconnected modules. The Basic UDI serves as the key data element linking these modules together. This interconnected structure ensures that regulatory bodies, manufacturers, and economic operators can efficiently track devices throughout their lifecycle. Properly aligning UDI submissions with these modules is essential for seamless compliance and data consistency.
“The interconnectivity of EUDAMED is really important because the Basic UDI family groupings are the key piece of data that is going to tie the different modules together. For example, your notified body certificates for the regulations will have your Basic UDI numbers indicated on them. And then that's connected to the Basic UDI numbers that you have associated to your single registration number.” - Adam Price
4. Deadlines, Compliance Risks, and Recommended Actions per Device Category
The deadline for mandatory UDI submissions to EUDAMED is January 1, 2026, with a six-month grace period until June 2026 for devices already on the market. Failure to meet these deadlines could result in compliance risks, including regulatory penalties and restricted market access. Different categories of devices are subject to specific rules:
- Regulated Devices: Devices compliant with MDR or IVDR regulations must be linked to Basic UDI groupings and classified accurately under EMDN. Recommended actions include ensuring all data aligns with the new requirements and preparing for immediate submissions of new devices after January 2026.
- Legacy Devices: Devices compliant with older EU directives that remain on the market do not require a Basic UDI but must still have all essential data submitted. Companies should consolidate and verify legacy data, ensuring consistency with prior regulatory approvals.
- Non-Registered Devices: Devices no longer placed on the market but still have post-market surveillance activities must be registered for traceability. Manufacturers should identify these devices, gather historical data, and ensure that post-market surveillance records are aligned with regulatory expectations
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5. Data Preparation and Submission Process
Data preparation for EUDAMED compliance is going to take some time, and the time to start preparing is now. It's important to recognize some of these high-level steps needed for effective UDI data preparation and submissions so that MedTech teams can plan appropriately:
- Identify: Collect and review all required UDI data, including language-specific fields and Basic UDI groupings.
- Verify: Ensure data accuracy and alignment with regulatory requirements, using EUDAMED’s business rules as a reference.
- Format: Structure data to meet EUDAMED’s formatting and enumeration rules, ensuring compatibility with submission methods.
- Submit: Transmit data using manual entry, XML uploads, or automated machine-to-machine (M2M) transmission, depending on the volume and complexity of your product portfolio.
“Ultimately, manufacturers need to be in a position to have all the data in for all products - not just the new products on the market but for all products by the end of that transitional period. It sounds a little apocalyptic but given the right planning, I think it's very achievable." - Adam Price
6. Getting Data into EUDAMED
Manufacturers have multiple options for submitting UDI data into EUDAMED, depending on their resources and portfolio size. Data can be manually entered through the EUDAMED user interface, uploaded via XML files, or submitted using automated machine-to-machine (M2M) transmission. Organizations managing large product portfolios are encouraged to adopt M2M transmission to ensure efficiency and data accuracy. Testing data submissions in the EUDAMED playground before official submission is highly recommended to identify and resolve any formatting or compliance issues.
“With more products, more data, and more BUDI families, there's more complexity. And as you're looking across your product portfolio, that's something that you need to consider as you plan your submission strategy.” -Adam Price
7. UDI Management Solutions
Organizations can choose from various UDI management solutions depending on their size and needs:
- Spreadsheets: Might be suitable for small companies with limited product portfolios but are time-consuming to manage and error-prone
- Repurposed Internal Systems: PLM or PIM systems can manage UDI data but may require manual processes and in-house expertise.
- Purpose-Built Connectors: Provide transmission capabilities for UDI data but don’t provide data capture and management
- RIM Systems (e.g., Rimsys): Provide a centralized, automated solution that integrates UDI data with product registrations and certificates, supporting seamless M2M transmissions.
“For large, complex product portfolios, RIM systems like Rimsys provide automated UDI management and seamless M2M transmissions.”
“Having an integrated data hub that's the source of truth for your UDI information is key. Then being able to associate your UDI data with all other data needed for UDI transmission in a RIM system, your registrations, certificates, legal entity, manufacturer, manufacturing locations, all the product data, all your BUDI data, having that all centralized in a RIM system is really critical to understanding and organizing your data in a way that can be meaningfully managed moving forward.” - James Gianoutsos
8. EUDAMED as a Foundation for Global UDI Compliance
There is a tremendous opportunity for EUDAMED’s comprehensive data requirements to serve as a foundation for global UDI compliance, as many countries are adopting similar regulations. Australia, Switzerland, the UK, and India are among the markets expected to enforce UDI requirements soon, with varying deadlines and data requirements. By using their EUDAMED data output as the foundation for a global UDI program, MedTech companies can build a UDI strategy that positions them to meet current and future requirements as they evolve.
“The application of UDI is not a one and done approach like it had possibly felt for manufacturers in the past. These requirements are going to need to be continually maintained from the perspective of your product characteristic data as well as new technologies as they're being introduced. So it's maintaining compliance to the current requirements, establishing compliance to the new countries’ UDI programs as those get rolled out, and being in a good position to control and consistently apply your UDI data.” -Adam Price
Conclusion
With the January 2026 deadline approaching, companies must act now to ensure compliance, streamline submissions, and prepare for future UDI requirements worldwide. Establishing a robust UDI strategy today will not only support compliance with EUDAMED but also lay the groundwork for expanding regulatory demands in other global markets. Leveraging centralized systems like RIM platforms can help manage the increasing complexity of global UDI regulations, ensuring consistent and efficient compliance.
“This seems to be a trend globally that UDI has become this single source data point to control and manage and maintain your products on the market. And so EUDAMED is just really the tip of the iceberg. Even though we know how complex it is, this is really just the beginning of this global UDI strategy that you have to be thinking about as you go into EUDAMED preparation.” -James Gianoutsos
Those interested in watching the webinar can access the recording here.
With an integrated and automated approach to UDI, Rimsys is a trusted and proven solution to help MedTech teams simplify EUDAMED compliance and assemble a global UDI program that meets current and future requirements. Request a custom demo rimsys.io/demo.
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