On-Demand Webinar: Harnessing Your Data for Medical Device Identification
The 12th annual UDI Conference is the industry gathering for medical device manufacturers, distributors, GPO’s and hospital systems to work through new and anticipated global UDI-related policies; dive into areas of confusion; create strategic roadmaps for cohesive implementation; grasp the impact on the healthcare ecosystem; and understand what is developing on the international UDI landscape.
Thoughts leaders from the FDA, device companies, solution providers, and consultancies led the discussions in this on-demand webinar.
What You'll Learn
- How global Unique Device Identification (UDI) requirements compare across the FDA, EU MDR/IVDR, and emerging regulators — and where their similarities and differences affect device manufacturers.
- The practical challenges of EU MDR and IVDR UDI application, including Basic UDI-DI, EUDAMED, and the role of authorized reps, importers, and distributors.
- Special UDI application requirements for systems, procedure packs, and IVD kits, and the QMS implications that come with them.
- How data quality and data management practices underpin device identification, traceability, and patient safety across multiple national systems.
- Why the melding of regulatory, commercial, and patient-safety use cases is reshaping how manufacturers build and maintain global UDI data systems.
Watch the videos below to see a preview of the discussion. Fill out the form and click Watch Now to access the full-length on-demand webinar. > > >
In this highlight video, see a sneak peek of Indira Konduri, FDA CDRH, discussing UDI in Recalls.
In this highlight video, see a sneak peek of Lionel Tussau, Healthcare Global Lead, atrify discussing New DI Triggers.
Agenda
The Global UDI Landscape
The final US UDI deadline will have passed (24 September 2022). The initial EU MDR/IVDR UDI label and package requirement deadline has also passed (MDR-complaint implantable and class III devices were 26 May 2021). More MDR and IVDR deadlines are fast approaching (e.g., MDR complaint Class IIa/b devices is 26 May 2023). At the same time, other regulators have (e.g., China, Singapore, Saudi Arabia, Columbia) or are working on (e.g., Canada, Australia, Egypt, Brazil) their UDI requirements. This session covers global UDI requirements, their similarities and differences, and their impact on device manufacturers.
Panelists:
- Jay Crowley, VP Medical Device Solutions, USDM Life Sciences
- Dennis Black, UDI Program Director, BD
- Geraldine Lissalde Bonnet, VP Healthcare, GS1 Global
- Indira Konduri, FDA CDRH
EU MDR & EU IVDR Challenges
The new EU medical device regulations (MDR and IVDR) introduce many new challenges for device manufacturers. This session addresses the many challenges and issues with MDR/IVDR UDI application, Basic UDI-DI (and Master UDI-DI), EUDAMED, the role of other economic operators (authorized reps, importers, distributors), the unique UDI application requirements for systems, procedure packs and IVD kits, and the various mandatory QMS implications. Managing those external operators is itself a discipline — see our perspective on third-party risk management in life sciences.
Panelists:
- Jay Crowley, VP Medical Device Solutions, USDM Life Sciences
- Lionel Tussau, Healthcare Global Lead, atrify
- Wendy Jackson, Fellow QA Engineer, Global UDI Program, Boston Scientific Corp
- Tania Pearson, Sr Regulatory Affairs Manager, Medtronic
Data Quality & Data Management Considerations
As regulators, purchasers, and other global stakeholders begin to develop and implement country or regulator-specific UDI or UDI-like systems – they are not only trying to address device identification – but also support particular national or local concerns (e.g., counterfeits, traceability, cost-control/reimbursement). These new regulatory, commercial, and patient-safety use-cases create novel and complex challenges for device manufacturers, who now must establish and maintain robust global systems and processes that allow them to develop, maintain and submit the ever-growing (and changing) information to these various systems and stakeholders. This session discusses the melding of these information needs and ways in which device manufacturers, healthcare providers, researchers, patients, purchasers, insurers, and regulators can work together to achieve the shared goals of improving device safety, effectiveness, healthcare quality, and patient safety, and reducing risks and healthcare costs. Because UDI submissions are only as trustworthy as the records behind them, data integrity in life sciences sits at the center of this session.
Panelists:
- Jay Crowley, VP Medical Device Solutions, USDM Life Sciences
- Terrie Reed, Chief Strategy Officer, Symmetric Health Solutions
- Gary Saner, Sr Mgr, Information Solutions, Reed Tech
- Ardi Batmanghelidj, President & CEO, Innovatum Inc.
USDM's point of view: UDI is no longer a single-market labeling exercise — it has become a global, multi-regulator data challenge. As the FDA, EU MDR/IVDR, and a growing list of national authorities each define their own requirements, the hardest part is not generating an identifier but maintaining accurate, submission-ready data across every system that consumes it. Manufacturers who treat UDI as a sustained data quality and governance program — not a one-time deadline — are the ones who keep devices compliant, traceable, and safe as the international landscape keeps shifting. Moderated by Jay Crowley, the original developer and author of the FDA's UDI requirements, this on-demand session brings that global perspective directly from the people writing and implementing the rules.
Frequently Asked Questions About Global UDI
What is Unique Device Identification (UDI)?
UDI is a system for identifying medical devices through their distribution and use. It enables device identification, supports traceability, and underpins the data that regulators, providers, and manufacturers rely on for device safety and effectiveness. This on-demand webinar walks through how UDI requirements now span the FDA, the EU, and a growing number of other regulators worldwide.
How do FDA UDI requirements differ from EU MDR and IVDR requirements?
While the goals overlap, the application details differ. The EU MDR and IVDR introduce concepts such as Basic UDI-DI, EUDAMED, and specific obligations for economic operators (authorized reps, importers, distributors), along with unique requirements for systems, procedure packs, and IVD kits. The webinar's “EU MDR & EU IVDR Challenges” session covers these differences and the QMS implications that come with them.
Which other countries are introducing UDI requirements?
Beyond the US and EU, the session notes that regulators such as China, Singapore, Saudi Arabia, and Columbia have UDI requirements, while others including Canada, Australia, Egypt, and Brazil are developing them. The “Global UDI Landscape” session compares these requirements and their impact on device manufacturers.
Why is data quality so important for UDI compliance?
Each regulator may consume UDI data for different purposes — device identification, counterfeit prevention, traceability, or cost-control and reimbursement. Manufacturers must build and maintain robust global processes to submit accurate, ever-changing information to many systems at once. Strong data integrity practices keep those submissions trustworthy. The records behind UDI submissions are also subject to electronic records expectations such as 21 CFR Part 11 compliance.
How can I watch the full UDI Beyond Borders webinar?
The full-length session is available on demand. Fill out the registration form on this page and click Watch Now to access the complete recording, including all three agenda sessions and the panel discussions.
Watch on demand: Fill out the form above and click Watch Now to stream the full UDI Beyond Borders conference. Have questions about your global UDI, EU MDR/IVDR, or medical device data strategy? Contact USDM Life Sciences to talk with our medical device solutions team.