# Challenges for Regulatory Submission: EU vs. US

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-05-06
- Length: 40m
- Episode: 259
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us
- Listen: https://podcast.greenlight.guru/episode/challenges-for-regulatory-submission-eu-vs-us

## Summary

Michelle Lott, Founder of leanRAQA and former FDA DGMPAC member, explains the severe regulatory hurdles of the EU MDR compared to the US FDA pathway, noting that 18,000 MDD certificates were issued but only 1% have transitioned to MDR. She highlights that companies face exorbitant notified body fees, a bottleneck of only 28 notified bodies, and the requirement for ISO 13485 certification, leading many small and large firms to withdraw from the EU market. Lott advises startups to perform a market analysis to determine if their revenue model supports these recurring costs, warning that 'hope is not a regulatory strategy' as certificates expire in May 2024. The discussion covers the shift from a linear US submission process to a continuous, living system in the EU, including annual audits and recertification every three years.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us#t=0) Introduction: Michelle Lott and leanRAQA
- [2:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us#t=141) The Reality of EU MDR Transition and Notified Body Bottlenecks
- [5:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us#t=336) Companies Withdrawing from the EU Market Due to Cost and Clinical Data
- [10:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us#t=625) Market Analysis and the Strategic Decision to Stay or Leave Europe
- [14:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us#t=891) Comparing EU MDR's Living System vs. US FDA's Linear Process
- [18:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us#t=1120) Impact on Startups, Fundraising, and Big MedTech Consolidation
- [34:28](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us#t=2068) Advocacy for Small Companies and FDA Comment Periods

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Green Light Guru (company)
- leanRAQA (company)
- FDA (other)
- EU MDR (other)
- ISO 13485 (other)
- Nestle (company)

## Related episodes from other shows

- [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)
- [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)
- [216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-03-216-how-uae-and-singapore-are-redefining-regulatory-innovation-with-stephen-orou) (Let's Combinate)
- [S6E19 Stuart Grant | MedTech Innovation](https://hardwarepodcasts.com/podcast/being-an-engineer/2025-05-09-s6e19-stuart-grant-medtech-innovation) (Being an Engineer)

## 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/2022-05-06-challenges-for-regulatory-submission-eu-vs-us. 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.