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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.
Navigating the Evolving Landscape of Medical Device Regulations and Digital Transformation
LexisNexis® Reed Tech® and 1WorldSync enable Global Medical Device Manufacturers to Manage Regulatory UDI submissions and Product Data Syndication. The collaboration pairs Reed Tech SingleSource™ for Medical Devices, which provides UDI regulatory data management technology, with 1WorldSync’s Global Data Synchronization Network (GDSN) capabilities. This allows MedTech companies to centrally manage and share product data required by global health authorities, customers, and stakeholders. The alliance assists the medical device industry in providing product information to regulatory systems, retailers, healthcare providers, and consumers, offering a comprehensive product data solution.
Tracking and Tracing Medical Devices: 4 Ways to Simplify Your UDI and GDSN Data Management Tracking medical devices...
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.
During early-stage drug concept and discovery, Pharmaceutical companies will find it necessary to research the market...
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).