# #339: UDI and the State of EUDAMED

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-10-12
- Length: 1h 02m
- Episode: 339
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed
- Listen: https://podcast.greenlight.guru/episode/339-udi-and-the-state-of-eudamed

## Summary

Richard Houlihan, founder of EirMed and former head of the European Commission's IT team for EUDAMED, explains the history, delays, and technical complexities of the European Database for Medical Devices. He details the shift from legacy systems to the new UDI Device Module, highlighting the massive data collation efforts required for compliance with the Medical Device Regulation (MDR). Houlihan warns that while the database is delayed until Q2 2025, companies must start preparing now to avoid legal sales bans and vigilance reporting failures.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed#t=0) Introduction and Richard Houlihan's Background
- [5:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed#t=358) History of EUDAMED and Data Quality Issues
- [12:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed#t=769) EUDAMED Timeline Delays and Audit Process
- [14:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed#t=844) Company Compliance Strategies and Master UDI
- [29:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed#t=1761) Comparing EUDAMED to FDA GUDID
- [34:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed#t=2053) Data Transparency and Market Intelligence
- [43:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed#t=2628) Vigilance Reporting and MDR Extensions
- [53:06](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed#t=3186) Advice for Small Companies and Training

## 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

companies scaling up

## Mentioned

- EUDAMED (other)
- EirMed (company)
- Greenlight Guru (company)
- FDA (company)
- GUDID (other)
- MDR (other)
- IVDR (other)
- KPMG (company)

## 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)
- [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)
- [099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi) (Let's Combinate)
- [069 - EU MDR Extension with Michelle Lott](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-25-069-eu-mdr-extension-with-michelle-lott) (Let's Combinate)
- [120 - EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr) (Let's Combinate)

## Citing this page

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