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In recent years, Unique Device Identification (UDI) regulations have been a focus topic for global health authorities. These regulations enhance patient safety, improve supply chain management, and facilitate efficient medical device recalls. Read on for a recap of recent updates and expected changes to UDI regulations from global health authorities.
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. As such, here is a detailed analysis that highlights the tangible benefits of opting for a single, global end-to-end solution platform, compared to managing multiple vendor platforms.
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.
The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project.
EUDAMED UDI Compliance is a critical aspect of the European Medical Device Regulation (MDR) that requires...