Technical Considerations and Guidance for Managing UDI Data to Meet the Deadline
On 23 January 2024, the European Union published the latest regulation, “amending Regulations (EU) 2017/745 [MDR] and (EU) 2017/746 [IVDR] as regards a gradual roll-out of Eudamed [European Database on Medical Devices], information obligation in case of interruption of supply and transitional provisions for certain in vitro diagnostic medical devices.”
Among the many changes to the Medical Devices Regulation (MDR) and In Vitro Diagnostic medical devices Regulation (IVDR), one of the most important is “to enable a gradual roll-out of the [EUDAMED modules] . . . that are finalised, instead of deferring the mandatory use of EUDAMED until the last of the six modules is completed.” The Regulation will “. . . enable a gradual implementation of individual EUDAMED modules once they have been audited and declared functional.”
The European Commission published an updated timeline for the mandatory implementation of EUDAMED (below). Where the previous EUDAMED timeline showed mandatory use starting in Q2 2029, the new timeline shows the mandatory use of unique device identification (UDI) and device registration starting from Q1 2026.
What You'll Learn
- How the EU's shift to a gradual, module-by-module EUDAMED roll-out moves mandatory UDI and device registration up from Q2 2029 to Q1 2026.
- How to read the amended MDR and IVDR requirements and translate the updated timelines into a practical compliance plan.
- How to handle MDR, legacy, and old (NRD – not to be registered) devices, plus other regional updates for the UK and Switzerland.
- How sustainability, supply chain disruption obligations, and EUDAMED connection options factor into your UDI data management approach.
What This On-Demand Webinar Covers
Watch this important on-demand webinar, co-hosted by USDM Life Sciences and BAYARD, to understand the requirements and regulatory implications for your business. You’ll learn more about:
- Overview of EUDAMED and Data Management
- Overview of New Amendment and Corresponding Timelines
- Review of MDR, Legacy, and Old (NRD – not to be registered devices)
- Other Regional Updates (UK and Swiss)
- Sustainability
- Supply Chain Disruptions
- Connection Options
- Q&A
Questions and answers are at the end of the presentation.
Why This Matters for Medical Device Manufacturers
EUDAMED registration is downstream of clean, consistent device data. Submitting UDI and device registration records into a regulated EU database requires the same discipline life sciences teams apply to other compliance obligations: trustworthy data, clear ownership, and validated processes. For organizations already managing 21 CFR Part 11 electronic records and a risk-based approach to systems through computer software assurance, EUDAMED readiness fits naturally into an existing quality and data governance model rather than standing apart from it.
About the Presenters
Jay Crowley, Vice President of Medical Device Solutions and Services USDM Life Sciences
At USDM, Jay provides business process, technology, and compliance solutions for the life sciences industry, and consults with medical device manufacturers to help them achieve regulatory compliance and a competitive advantage with UDI implementation. Previously, Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. He developed the framework and authored key requirements for the FDA’s Unique Device Identification system.
Lionel Tussau, Lead Healthcare, BAYARD
Lionel is responsible for developing healthcare activities at Bayard Consulting, including supporting manufacturers to register UDI data into regulatory databases like EUDAMED or the Global Unique Device Identification Database (GUDID), sharing sustainability and product information with trading partners, and leveraging the GS1 Global Data Synchronisation Network (GS1 GDSN). He represents Bayard in MedTech Europe (chairman of the EUDAMED IT Expert group), is an observer in the EUDAMED Medical Device Coordination Group (MDCG) working group, and is a GS1 Global Healthcare Leadership Team member.
FAQ: Mandatory Use of EUDAMED in Q1 2026
When does mandatory use of EUDAMED begin?
Under the regulation the European Union published on 23 January 2024, the European Commission's updated timeline moves the mandatory use of unique device identification (UDI) and device registration to Q1 2026. The previous EUDAMED timeline had shown mandatory use starting in Q2 2029.
What changed with the gradual roll-out of EUDAMED?
The amended Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) enable a gradual roll-out of the EUDAMED modules that are finalised, instead of deferring mandatory use until the last of the six modules is completed. Individual modules become mandatory once they have been audited and declared functional.
Which devices does this webinar address?
The session reviews MDR devices, legacy devices, and old (NRD – not to be registered) devices, so manufacturers can understand how the updated timelines apply across their portfolio. It also covers other regional updates for the UK and Switzerland.
What other topics does the session cover beyond timelines?
Beyond EUDAMED data management and the new amendment timelines, the webinar covers sustainability, supply chain disruptions, and EUDAMED connection options, and closes with a live question-and-answer segment with the presenters.
Who presents this webinar?
It is co-hosted by USDM Life Sciences and BAYARD, featuring Jay Crowley, Vice President of Medical Device Solutions and Services at USDM Life Sciences, and Lionel Tussau, Lead Healthcare at BAYARD.
Watch the On-Demand Webinar
Register to watch the full on-demand session and get the presenters' detailed walkthrough of the updated EUDAMED timelines, device categories, regional updates, and connection options. If you'd like to discuss how the Q1 2026 deadline affects your UDI data and registration readiness, contact USDM Life Sciences to talk with our medical device compliance team.