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
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...
Reed Tech Takeaways from RAPS Euro Convergence
Greetings from Amsterdam! Earlier this month, Sales Development Representative Miriam Kniering represented Reed Tech...
EU Amendment to Extend Legacy Medical Device Transition
In recent news, the European Commission passed an extension (EU Regulation 2023/607) to the transition deadline for...
What the EU EUDAMED Timeline Means for Your Product and What to Do Now
Update on the EU EUDAMED Timeline On 6 July 2022, the European Commission (EC) updated the publicly posted timeline...