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

Medical Devices, Unique Device Identification

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

Medical Devices, Unique Device Identification

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

Medical Devices, Unique Device Identification

Explore the significance of the AusUDID rollout, its objectives, and how the TGA requirements for UDI differ from FDA regulations.

Embracing EUDAMED UDI Compliance Timing: Why Starting the Process Now is Crucial for Medical Device Manufacturers

Medical Devices, Unique Device Identification

EUDAMED UDI Compliance is a critical aspect of the European Medical Device Regulation (MDR) that requires...

Understanding FDA Exemptions to Unique Device Identification (UDI) Requirements

Medical Devices, Unique Device Identification

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

Medical Devices, Unique Device Identification

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

Medical Devices, Unique Device Identification

The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database (GUDID).