The clock is ticking. By early 2026 (unless your Notified Body “requests” it sooner), medical device manufacturers must ensure full, accurate, and compliant registration of all applicable legacy and regulation devices in EUDAMED. With various, complex deadlines looming and regulatory expectations intensifying, many organizations are underprepared for the complexity and rigor of the process.
In this on-demand webinar, USDM Life Sciences and BYRD Health domain experts unveil the essential strategies for achieving audit-ready EUDAMED compliance—efficiently, confidently, and on time. Drawing from extensive hands-on experience guiding medical device companies into EUDAMED, this session goes beyond the regulatory checklist. You’ll gain practical insights into how future-focused manufacturers are transforming compliance into a competitive advantage.
What You’ll Learn
- Critical UDI pitfalls to avoid under MDR — how inconsistent data entry, system limitations, and a lack of global harmonization can create hidden risks.
- Validated environments and digital quality management best practices — why “good enough” won’t cut it anymore, and how to achieve continuous compliance in a tech-enabled quality framework.
- Global UDI data alignment — how to streamline compliance across EUDAMED, GUDID, and other international systems while reducing redundancy and complexity.
- Self-registration vs. solution provider — the real-world pros and cons, and why strategic partnerships can mean the difference between success and setback.
- Lessons learned from peers already in production — how to accelerate your own journey using proven blueprints.
Why EUDAMED Compliance Can’t Wait
What’s at stake if you delay? Risk exposure. Regulatory setbacks. Market access disruptions. But with the right strategy and support, you can turn this challenge into a catalyst for long-term operational resilience and innovation. Because 2025 compliance is closer than you think—and falling behind is not an option. This session gives you the foresight, frameworks, and partner insight you need to avoid common missteps and stay ahead of evolving EU regulations.
USDM’s point of view: EUDAMED registration is not a one-time data-entry exercise—it is an ongoing continuous compliance commitment that lives at the intersection of regulatory strategy, data integrity, and validated quality systems. Manufacturers who treat UDI and EUDAMED as a connected, governed data program—rather than a deadline-driven scramble—turn a regulatory obligation into durable global market readiness.
Who Should Watch?
Regulatory, Quality, and IT leaders in medical device organizations who are responsible for compliance strategy, data management, and global market readiness. If your validated systems and data integrity practices underpin your submissions, this session is built for you.
Watch the On-Demand Webinar
Take control of your EUDAMED strategy—before the deadlines control you. Fill out the form to watch this session on demand. Have questions about your EUDAMED or UDI program? Contact USDM to talk with our medical device solutions team.
Presenter Bios
Lionel Tussau, Lead Healthcare, BYRD Health
Lionel Tussau is the Lead Healthcare at BYRD Health, an osapiens company, with over 20 years of experience in product data management for the healthcare sector. He currently serves as Chair of the MedTech Europe EUDAMED IT group and is a member of the GS1 Global Healthcare leadership team.
Lionel supports the entire healthcare ecosystem in managing product information—ranging from UDI registration and data exchange between trading partners to meeting sustainability reporting requirements. His deep expertise in healthcare technology and services, combined with active collaboration with regulators, GS1 organizations, trade associations, and other key stakeholders, contributes to building a safer, more transparent environment for patients.
Jay Crowley, Vice President, Medical Device Solutions and Services, USDM Life Sciences
Jay Crowley is Vice President of Medical Device Solutions and Services at USDM Life Sciences, where he leads UDI solutions and services for the regulated life sciences industry. A globally recognized expert on Unique Device Identification (UDI), Jay developed the framework and authored key requirements for the U.S. FDA’s UDI System.
With over 26 years at the FDA, Jay held several leadership roles across the Office of the Commissioner, the Office of Compliance, and the Center for Devices and Radiological Health, where he most recently served as Senior Advisor for Patient Safety. His work focused on design control regulations, adverse event reporting, and improving patient safety.
At USDM, Jay provides strategic guidance to medical device manufacturers, helping them implement UDI to meet regulatory requirements while driving operational efficiency and competitive advantage.
EUDAMED & UDI Compliance FAQ
What is EUDAMED and why does it matter for medical device manufacturers?
EUDAMED is the European database for medical devices. Under the EU Medical Device Regulation (MDR), manufacturers must ensure full, accurate, and compliant registration of all applicable legacy and regulation devices in EUDAMED. Incomplete or inaccurate registration can lead to risk exposure, regulatory setbacks, and market access disruptions in the EU.
When are the EUDAMED registration deadlines?
The session is framed around deadlines arriving in early 2026—and notes that your Notified Body may “request” registration sooner. Because the deadlines are complex and staggered across device types, manufacturers are encouraged to begin preparing well ahead of the dates rather than waiting until they are imminent.
How does EUDAMED relate to UDI and systems like GUDID?
EUDAMED registration depends on consistent Unique Device Identification (UDI) data. The webinar covers how to align UDI data across EUDAMED, the U.S. FDA’s GUDID, and other international systems—reducing redundancy and complexity while avoiding the data-quality pitfalls that create hidden compliance risk.
Should we self-register or work with a solution provider?
The session walks through the real-world pros and cons of self-registration versus partnering with a solution provider, including why strategic partnerships can mean the difference between a smooth path and costly setbacks for many manufacturers.
How do validated environments and digital quality management fit in?
The webinar explains why a “good enough” approach no longer meets expectations, and how validated environments and a tech-enabled, digital quality management framework support continuous compliance. USDM applies computer software assurance and 21 CFR Part 11 practices to keep these systems audit-ready over time.