# UDI and the Current State of Global Implementation

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-08-18
- Length: 45m
- Episode: 276
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-18-udi-and-the-current-state-of-global-implementation
- Listen: https://podcast.greenlight.guru/episode/udi-and-the-current-state-of-global-implementation

## Summary

Gary Saner, Senior Manager of Information Solutions at Reed Tech, discusses the complexities of Unique Device Identification (UDI) implementation in the US and EU. He details the FDA's Class I UDI deadlines, the four quadrants of compliance, and the data challenges of submitting to GUDID. Saner contrasts this with the EU's MDR/IVDR overhaul, explaining the EUDAMED database, the 'Basic UDI-DI' concept, and the lack of global harmonization.

## Chapters

- [0:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-18-udi-and-the-current-state-of-global-implementation#t=20) Introduction and FDA Class I UDI Deadlines
- [9:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-18-udi-and-the-current-state-of-global-implementation#t=565) The Four Quadrants of UDI Compliance
- [14:09](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-18-udi-and-the-current-state-of-global-implementation#t=849) Data Collection and Submission Methods
- [20:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-18-udi-and-the-current-state-of-global-implementation#t=1200) EU MDR/IVDR Implementation and EUDAMED
- [34:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-18-udi-and-the-current-state-of-global-implementation#t=2098) Global Harmonization and Regional Differences

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

large enterprises

## Mentioned

- Green Light Guru (company)
- Reed Tech (company)
- FDA (company)
- GUDID (other)
- EUDAMED (other)
- EMDN (other)

## Related episodes from other shows

- [054 - "EUDAMED" with Richard Houlihan](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan) (Let's Combinate)
- [031 - "The Five Stages Of Regulatory Grief" with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2022-05-04-031-the-five-stages-of-regulatory-grief-with-michelle-lott) (Let's Combinate)
- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (Let's Combinate)
- [139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-05-139-fda-platform-guidance-ema-q-a-guidance-for-drug-device-combinations-usp-and) (Let's Combinate)
- [130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-18-udi-and-the-current-state-of-global-implementation. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.