LexisNexis Reed Tech
Webinars
Stay ahead with LexisNexis Reed Tech webinars on Pharmaceutical & Medical Device regulations.
ON DEMAND WEBINAR
Coffee Talk: Breaking Down the EU’s Latest EUDAMED Functional Confirmation
On 2025-Nov-27, the European Commission published a EUDAMED Functional Notice
in the Official Journal of the European Union (OJEU) announcing that several major EUDAMED modules:
- Actors Registration
- UDI/Devices
- Notified Bodies & Certificates
- Market Surveillance
“have achieved functionality and meet the functional specifications.”
This notice marks a significant milestone toward full EUDAMED implementation. It also signals that manufacturers should intensify their preparations for data readiness, system integration, and upcoming submission timelines.
In This On-Demand Webinar, You Will Learn:
- What this Functional Notice means in practice
- How it impacts device manufacturers
- What actions organizations should prioritize now
- How to assess data readiness for the live modules
- What still remains to be finalized by the Commission
Why It Matters Now
EUDAMED readiness has reached a new stage. On November 27, 2025, the European Commission formally confirmed in the OJEU that the Actors, UDI/Devices, Notified Bodies/Certificates, and Market Surveillance modules meet the required specifications.
This notice accelerates expectations for manufacturers. Therefore, organizations must ensure their device data is complete, consistent, and ready for submission once final timelines are confirmed. In this session, we explain what this update means for your regulatory strategy and how to prepare your systems and processes for the next phase of EUDAMED activation.
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Panelist
Gary Saner is a Sr. Manager of Information Solutions in the Reed Tech group. He is a subject matter expert on Drug Labeling, Medical Device UDI, and other structured content reporting to regulatory agencies and commercial organizations. He has over 40 years of experience in software development, process management, and data administration, with the last 19 years focused on the Life Sciences industry. With a deep understanding of regulations, business requirements, and systems, he has helped shape and implement successful solutions at Reed Tech for data management, validation, processing, and submission of Drug Labeling content, Cosmetic information, and Medical Device UDI data. He serves as chair of the industry’s Structured Product Labeling (SPL) Technical Team.
