The State of UDI Across the World

March 7, 2024


In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Gary Saner, a seasoned expert in medical device Unique Device Identification (UDI) and regulatory compliance.

They embark on a comprehensive exploration of the ever-evolving landscape of UDI requirements, shedding light on crucial deadlines, common pitfalls, and strategic insights for achieving global compliance.

From the intricacies of European UDI requirements to the specifics of implementing UDI systems in markets like Australia and beyond, this episode is a treasure trove of actionable insider knowledge for medical device professionals navigating the complexities of UDI compliance.

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Key Takeaways

Latest MedTech Trends:
  1. Increasing global adoption of UDI requirements signifies a move towards standardized device identification for enhanced patient safety.
  2. The push towards digital transformation in regulatory compliance highlights the industry's shift towards efficiency and data accuracy.
  3. The growing complexity of global UDI regulations challenges manufacturers to adopt flexible and scalable solutions for compliance.
Practical Tips for Listeners:
  1. Start early with your UDI compliance strategy to accommodate the evolving nature of global regulations.
  2. Engage with experts and consider leveraging technology solutions like ReTech for streamlined compliance processes.
  3. Stay informed about regulatory changes in key markets to ensure continuous compliance and market access.
Predicting Future Developments:
  1. Will AI and machine learning play a more significant role in automating UDI compliance processes?
  2. How will the expansion of UDI requirements into emerging markets affect global medical device distribution?
  3. Can we expect a universal standard for UDI compliance to emerge, simplifying global regulatory landscapes?


Memorable quote:

"UDI has this ongoing life connected to just doesn't seem to end. Once you do it, you're not done; you have to keep opening those books and making changes." - Gary Saner


Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at


This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

About the Global Medical Device Podcast:

Untitled (8.5 × 3 in)

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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