The European Database on Medical Devices (EUDAMED) Device Registration and UDI Database module is now available for use
No longer a sandbox, device manufacturers can enter Basic Unique Device Identification Device Identifier (Basic UDI-DI) and UDI-DI information into EUDAMED using real data. In this on-demand webinar, regulatory experts walk through why and how to start using the module now.
According to the European Commission, this is a Minimum Viable Product (MVP), so additional functionality will be added later, but it does allow full registration of devices. Still, there are issues to be aware of and concerns about how this module will (or will not) evolve as we advance toward a fully functional EUDAMED.
What you'll learn
- How the Medical Device Regulation (MDR) and EUDAMED fit together, and what the now-live UDI Database module means for device manufacturers.
- How to make best use of actor registration as the entry point to EUDAMED.
- Why and how to register UDI information in EUDAMED now, using real Basic UDI-DI and UDI-DI data rather than the sandbox.
- What to watch for given EUDAMED's Minimum Viable Product (MVP) status and the future steps still to come.
- Answers to live audience questions in the Q&A session.
Inside the discussion
The discussion included:
- Medical Device Regulation (MDR) and EUDAMED
- Actor registration – How to make best use of it
- UDI Registration in EUDAMED – Why and how to use it now
- EUDAMED future steps
- Q&A
Why this matters: Registering UDI data correctly in EUDAMED is more than a one-time data-entry task — it is an ongoing compliance obligation that touches your quality system, your data governance, and the integrity of the device records you submit to a live regulatory database. Treating EUDAMED registration as a managed, validated process rather than a manual scramble is how device manufacturers stay audit-ready as the system evolves from MVP toward full functionality. USDM helps life sciences organizations build that discipline into their data integrity and quality practices.
About the Presenters
Lionel Tussau, Director, Strategic Industries, atrify
Lionel is leading the global healthcare strategy at the product content solution provider atrify, a company enabling UDI registrations into regulatory databases (such as EUDAMED) and GDSN connections between manufacturers, wholesalers, GPOs, and hospitals. He represents atrify in MedTech Europe (chairman of the EUDAMED IT Expert group), is an observer in the EUDAMED MDCG working group, and is a member of the GS1 Global Healthcare Leadership Team.
Jay Crowley, Vice President of Medical Device Solutions and Services, USDM Life Sciences
Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.
Frequently asked questions about UDI registration in EUDAMED
What is the EUDAMED UDI Database module?
EUDAMED is the European Database on Medical Devices. Its Device Registration and UDI Database module lets device manufacturers register devices and enter Basic Unique Device Identification Device Identifier (Basic UDI-DI) and UDI-DI information. It is now live and available for use with real data — it is no longer a sandbox.
Can I register devices in EUDAMED now using real data?
Yes. The module is no longer a sandbox, so manufacturers can enter Basic UDI-DI and UDI-DI information using real data and complete full registration of devices. The webinar explains why and how to start using it now.
Is the EUDAMED UDI module fully complete?
According to the European Commission, the module is a Minimum Viable Product (MVP). It allows full registration of devices today, but additional functionality will be added later. There are also issues to be aware of and open questions about how the module will evolve toward a fully functional EUDAMED. Approaching that evolving submission process with a validated mindset — the kind reflected in computer software assurance thinking — helps keep your device records reliable as the module matures.
How does actor registration relate to UDI registration?
Actor registration is part of how organizations establish themselves in EUDAMED under the Medical Device Regulation (MDR). The webinar covers how to make best use of actor registration as you prepare to register UDI information.
How do I keep EUDAMED registration accurate as the module evolves?
Because EUDAMED is still maturing from its MVP state, keeping your registered device data accurate is an ongoing effort rather than a single submission. A continuous, managed approach — the same posture USDM brings to cloud assurance — helps device manufacturers stay current as EUDAMED's future steps arrive.
What does USDM recommend as a next step?
Treat EUDAMED registration as a managed, validated compliance process tied to your quality and data integrity practices. To talk through your MDR and UDI registration approach with USDM's medical device experts, contact us.
Watch the webinar on-demand
Watch this on-demand session to hear Lionel Tussau and Jay Crowley walk through MDR, actor registration, UDI registration in EUDAMED, and what comes next — plus the live Q&A.
Have questions about UDI registration, MDR readiness, or building a validated, audit-ready compliance process? Contact USDM Life Sciences to speak with our medical device and quality experts.