# [LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-04-22
- Length: 30m
- Episode: 143
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem
- Listen: https://podcast.greenlight.guru/episode/live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem

## Summary

Jon Speer hosts a live discussion with Evangeline Loh, Vice President of Regulatory Affairs at Emergo Group, regarding the impact of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) on the medical device ecosystem. They detail critical regulatory shifts, including the delay of the EUDAMED database to 2022, the up-classification of self-certified Class I devices under Corrigendum 2, and the severe bottleneck caused by having only 11 designated Notified Bodies. The conversation highlights the strategic advantage of securing legacy MDD certification before May 2020 to avoid MDR compliance until 2024, while also addressing the regulatory duplication and market access challenges introduced by Brexit.

## Chapters

- [0:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem#t=21) Introduction: Jon Speer and Evangeline Loh at Greenlight Guru True Quality Roadshow
- [3:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem#t=227) EU MDR Timeline: EUDAMED Delay and Corrigendum 2 for Class I Devices
- [8:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem#t=531) Notified Body Bottleneck: Only 11 Bodies Designated and Capacity Issues
- [11:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem#t=682) Legacy Device Strategy: Securing MDD Certification Before May 2020
- [14:05](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem#t=845) Brexit Impact: UK Market Access and Notified Body Relocation
- [18:26](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem#t=1106) Uncertainty and Legacy Device Ambiguities Post-Application Date
- [21:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem#t=1285) Audience Q&A: Startup Timelines and IVDR Up-classification Challenges

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

large enterprises

## Mentioned

- Emergo Group (company)
- EUDAMED (other)
- MHRA (other)
- BSI (company)
- NANDO (other)
- IVDR (other)
- ISO 13485 (other)

## Related episodes from other shows

- [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)
- [051 - "EU MDR" with Bassil Akra](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra) (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)
- [054 - "EUDAMED" with Richard Houlihan](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan) (Let's Combinate)
- [074 - Article 117, EU MDR extension, Notified Body Opinions, Timing and Interaction with Christiana Hoffman](https://hardwarepodcasts.com/podcast/lets-combinate/2023-03-01-074-article-117-eu-mdr-extension-notified-body-opinions-timing-and-interaction-w) (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/2020-04-22-live-how-eu-mdr-changes-are-impacting-the-medical-device-ecosystem. 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.