UDI and Product Data
This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices to manage medical device product data for established and newly formed Health Authority UDI mandates around the world.
Recent Blogs
UDI Implementation Tips and GDSN Data Management
Tracking and Tracing Medical Devices: 4 Ways to Simplify Your UDI and GDSN Data Management Tracking medical devices...
EC Proposal Updates on IVDR Transition & EUDAMED Rollout
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.
Reed Tech Submits First M2M UDI Submission to the AusUDID Pre-Production System
In recent news, Reed Tech became the first company to submit a device record (machine-to-machine) to the AusUDID Pre-Production system successfully.
Understanding Basic UDI-DI in EUDAMED
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.
Update on EUDAMED Timeline
The EUDAMED timeline has experienced several delays and revisions since its inception, primarily due to the complexity and magnitude of the project.
Navigating the AusUDID Rollout: A New Era for Medical Device Identification
Explore the significance of the AusUDID rollout, its objectives, and how the TGA requirements for UDI differ from FDA regulations.
Understanding FDA Exemptions to Unique Device Identification (UDI) Requirements
The Food and Drug Administration (FDA) has implemented the Unique Device Identification (UDI) system to enhance...
Understanding FDA UDI Compliance Requirements for Medical Device Manufacturers
What are the potential consequences for medical device manufacturers not following through with product data...
Med Devices Missing in GUDID and Obsolete GMDN Codes in GUDID
Courtesy notification of news from FDA: The U.S. Food and Drug Administration (FDA) recently initiated two initiatives...