Last week, the European Commission released a Q&A on practical aspects related to implementing the gradual roll-out of EUDAMED. In the following blog, we will cover highlights from the document and recommendations for the next steps.

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Last week, the European Commission released a Q&A on practical aspects related to implementing the gradual roll-out of EUDAMED. In the following blog, we will cover highlights from the document and recommendations for the next steps.
As we continue to discuss optimal solutions to support the growth and compliance needs of industry, LexisNexis Reed Tech is committed to providing you with a single UDI vendor and platform.
On Tuesday, October 15, 2024, Reed Tech and 1WorldSync hosted a highly informative webinar led by Gary Saner, Senior Regulatory Principal at Reed Tech, and Scott Brown, Senior Director of Global Data Strategy at 1WorldSync. The webinar focused on how their continued alliance helps companies navigate Unique Device Identification (UDI) management and utilize the Global Data Synchronization Network (GDSN) to meet regulatory compliance requirements.
With the EUDAMED go-live date rescheduled multiple times, manufacturers face conflicting strategies of when to make UDI/Device registration submissions to EUDAMED.
LexisNexis® Reed Tech, a leading provider of regulatory submissions, data management, and analytics solutions for the life sciences industry, is expanding its services portfolio to a varied suite of regulatory compliance solutions and services to support medical device manufacturers, distributors, and related operations.
On January 23, 2024, the European Commission proposed a legislative amendment to address two major issues in the EU Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).
Quick Insights from our experts on the EC Proposal concerning the IVDR transition and proposed MDR/IVDR amendment, possibly affecting the EUDAMED rollout. These are short segments created from our latest presentation, prepared exclusively for UDI customers.
Start the year with clean data and a firm understanding of what you must do for EUDAMED UDI compliance in 2024. UDI compliance readiness can be confusing. To help, we’ve gathered top tips from expert Gary Saner regarding upcoming milestones in the EUDAMED roadmap.
By submitting product data to health authority databases, the medical device industry can help ensure the safety and traceability of devices. One crucial element is the European Commission/EUDAMED-specific concept of Basic UDI-DI.
The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project.