# 054 - "EUDAMED" with Richard Houlihan

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-10-12
- Length: 28m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/054---EUDAMED-with-Richard-Houlihan-e1p33cb

## Summary

Richard Houlihan, CEO of Eirmed, discusses the history, structure, and compliance requirements of EUDAMED, the European Commission's medical device database. He details the system's six modules, highlighting the complexity of the clinical investigations module and the shift from private competent authority access to public transparency for device data. Houlihan explains the legal obligations for economic operators, including manufacturers, authorized representatives, and importers, emphasizing that EUDAMED is a mandatory cost of doing business in Europe with strict data validation rules.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan#t=0) Introduction: Richard Houlihan and Eirmed
- [1:40](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan#t=100) Houlihan's Background and EUDAMED History
- [3:04](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan#t=184) EUDAMED Development Delays and Module Complexity
- [7:11](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan#t=431) European Commission Working Groups and Language
- [10:23](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan#t=623) Evolution from EUDAMED 2 to MDR EUDAMED
- [15:27](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan#t=927) Comparison with US FDA Databases
- [17:14](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan#t=1034) Transparency Goals and Patient Safety
- [20:21](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan#t=1221) Legal Obligations for Economic Operators
- [25:51](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan#t=1551) Definition of Fully Functional and Future Steps

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)

## Most relevant to

early-stage companies

## Mentioned

- Eumed (company)
- EUDAMED (other)
- European Commission (other)
- FDA (other)

## Related episodes from other shows

- [#339: UDI and the State of EUDAMED](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed) (Global Medical Device Podcast)
- [[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem) (Global Medical Device Podcast)
- [Bridging the Gap between Medical Devices and Clinical Data](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data) (Global Medical Device Podcast)
- [Explaining the Role of Importer under EU MDR](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr) (Global Medical Device Podcast)
- [UDI and the Current State of Global Implementation](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-18-udi-and-the-current-state-of-global-implementation) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan. 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 Let's Combinate.