The countdown to mandatory EUDAMED compliance is on.
With the January 2026 deadline fast approaching, medical device manufacturers across the globe are racing to meet new regulatory expectations.
The Short Version
- January 2026 marks the mandatory transition to EUDAMED—national competent authority registration phases out once the database becomes required.
- If a device isn't registered when UDI registration becomes mandatory, it cannot be placed on the market.
- MDR and MDD products already on the market face a July 2026 UDI registration milestone—but waiting until the last moment is risky.
- Building your own EUDAMED Access Point can take 3–6 months, making DIY connections risky this late in the game.
- EUDAMED is one node in a web of international UDI databases—success demands a validated environment and a single source of truth.
In a recent webinar hosted by USDM Life Sciences and BYRD Health, industry experts Jay Crowley, Lionel Tussau, and Jim McDonald tackled some of the most critical questions surrounding EUDAMED implementation.
If you missed the session or want a deeper dive into the Q&A, we’ve captured the highlights below—along with expert commentary to bring clarity and context to each answer.
Q: If the data model is not generally available, how does a company do this correctly? How can USDM and BYRD help?
While the data dictionary is available, the real challenge lies in interpreting documented and undocumented business rules. As Lionel Tussau noted in the webinar, “It's not about what's in the documentation—it's about what’s missing.” BYRD and USDM bring deep, hands-on experience to the table, helping manufacturers navigate these nuances to avoid common pitfalls in data submission. Getting this right starts with disciplined data integrity across every record headed to EUDAMED.
“It's not about what's in the documentation—it's about what’s missing.” — Lionel Tussau
Q: What happens if I don’t register my products on time?
Quite simply, you cannot sell them. “Once the UDI registration becomes mandatory, if a product isn't registered, it cannot be placed on the market,” said Jay Crowley.
Q: When can I stop using national competent authorities and rely solely on EUDAMED?
January 2026 marks the mandatory transition. However, some countries like France have already shifted to EUDAMED. National authority registration will phase out completely once the database is required.
Watch the full on-demand webinar. The complete session goes deeper into validation frameworks, submission timelines, and global UDI strategy. Access the recording here.
Q: Do I need to register IVDR devices with EUDAMED by January 2026 even if they’re not yet on the market?
No. Only devices that are placed on the market must be registered. However, if you’re placing directive versions of new devices, those must be registered as well.
Q: Could registering CE-marked products in EUDAMED create overlap with Swiss and Australian UDI databases?
Yes, overlap is a real concern. Lionel noted that each jurisdiction has its own data model and rules, reinforcing the need for a holistic, global strategy that accounts for cross-regional compliance.
Q: If my MDR product is already on the market, what’s the UDI registration deadline?
July 2026 is the key milestone. That said, waiting until the last moment is risky. Jay emphasized that other stakeholders (like notified bodies and tender authorities) may push for earlier registration.
Q: What about MDD products already on the market?
The same July 2026 deadline applies, but only if those products are still being placed on the market after January 2026. Understanding what qualifies as a “same” device under regulation is critical to avoid unnecessary dual registrations.
Q: Who’s responsible if a manufacturer uses an OEM device?
The legal manufacturer bears full responsibility for UDI and EUDAMED registration—even if an OEM is involved. This is where third-party risk management becomes essential, since responsibility for the registration does not transfer to the supplier.
Q: Are Class I devices subject to different UDI timelines?
No. All classes follow the same registration deadlines under the EUDAMED rollout. There’s no phased approach based on risk class, unlike the U.S. implementation.
Q: In countries like Portugal, Spain, and Italy, is local registration still mandatory?
For now, yes. But these national requirements will be replaced by EUDAMED once it becomes mandatory in January 2026.
Q: Device Name vs. Device Model—what’s required under Basic UDI-DI?
Either one is required and both can represent a device family. The specific product is identified by the trade name in the UDI-DI record.
Q: Does “registered” mean loaded into EUDAMED or does it have to reach a certain status?
"Submitted" is sufficient from the manufacturer's perspective, though there’s ambiguity without formal guidance from the European Commission. Some external stakeholders may expect to see a "registered" status.
Q: What’s the process to get an Access Point for Playground or Production EUDAMED?
It’s a lengthy and complex process. Setup can take 3–6 months, making it risky for companies attempting to build their own connections this late in the game. Jay and Lionel both recommend leveraging existing machine-to-machine solution providers like BYRD to meet timelines.
Strategic Takeaways from the Experts
Throughout the webinar, several key strategies emerged for success:
The EUDAMED Readiness Playbook
- Don’t go it alone. DIY approaches are fraught with risk due to undocumented rules, hidden dependencies, and minimal support.
- Start now—or risk falling behind. The “big bang” go-live in January 2026 leaves no buffer for last-minute implementation.
- Think globally. EUDAMED is just one node in a web of international UDI databases. A single source of truth and validated environment is essential.
- Use a validated platform. The USDM Cloud Assurance™ certification for BYRD ensures a continuously compliant environment—a major advantage when data accuracy, traceability, and audit-readiness are non-negotiable.
That validated, continuously compliant foundation is exactly what USDM Cloud Assurance is built to deliver—keeping the systems behind your UDI submissions audit-ready as regulations evolve.
Ready to Dive Deeper?
These answers are just the beginning. The full on-demand webinar goes into even greater detail, covering validation frameworks, submission timelines, risk mitigation strategies, and how to operationalize global UDI compliance.
How USDM Can Help You Succeed
At USDM Life Sciences, we’ve helped over 150 medical device companies simplify their UDI compliance journey. With the January 2026 EUDAMED deadline fast approaching, now is the time to assess your readiness and take strategic action. We partner with you to ensure you achieve a UDI-ready state—on time, with confidence, and without disruption to your operations.
Our end-to-end UDI services include:
- Global UDI Regulatory & Program Planning
- QMS Revisions
- Label, Data Management, IFUs, Packaging Reviews & Guidance
- Data Collection, Cleaning, MDM, Maintenance & Submissions
- UDI MDM / Submission Apps Implementation, Validation & Release Management
- New Regulation / New Agency Planning & Support
- AI support and integration for medical device manufacturers
Many of these submission and MDM applications are validated software systems in their own right—so a disciplined computer software assurance (CSA) approach keeps your validation effort proportionate to risk while staying defensible under audit.
Whether you’re just starting or fine-tuning your compliance strategy, our proven methodologies and validated solutions will help you scale globally and stay ahead of evolving regulations.
FAQ: EUDAMED Compliance and UDI Registration
When does EUDAMED become mandatory?
January 2026 marks the mandatory transition to EUDAMED. Some countries, such as France, have already shifted to it. Once the database is required, national competent authority registration phases out completely.
What happens if I don’t register my products in time?
You cannot place them on the market. As Jay Crowley put it, once UDI registration becomes mandatory, an unregistered product cannot be sold.
What is the UDI registration deadline for products already on the market?
July 2026 is the key milestone for MDR products already on the market. The same July 2026 deadline applies to MDD products, but only if they are still being placed on the market after January 2026.
Do Class I devices follow a different timeline?
No. All classes follow the same registration deadlines under the EUDAMED rollout. There is no phased approach based on risk class, unlike the U.S. implementation.
How long does it take to set up an EUDAMED Access Point?
Setup can take 3–6 months, which is why building your own machine-to-machine connection this late in the game is risky. Many manufacturers leverage established solution providers like BYRD to meet timelines.
Take Control of Your EUDAMED Strategy
Take control of your EUDAMED strategy—before the deadlines control you. Contact USDM today to assess your UDI readiness and build a validated, audit-ready path to compliance.