# 069 - EU MDR Extension with Michelle Lott

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-01-25
- Length: 17m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-25-069-eu-mdr-extension-with-michelle-lott
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/069---EU-MDR-Extension-with-Michelle-Lott-e1tigi0

## Summary

Michelle Lott, founder of leanRAQA, explains that the EU MDR extension is not a simple delay but a conditional pathway for companies that have actively transitioned their quality systems. She details two routes to extend certificates: submitting to national competent authorities or obtaining derogation from notified bodies, both requiring proof of effort and capacity constraints. Lott highlights that over 50% of technical files are rejected initially and notes that notified bodies are now selective, preferring clients who are prepared and easy to work with.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-25-069-eu-mdr-extension-with-michelle-lott#t=0) Introduction to EU MDR Extension
- [1:37](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-25-069-eu-mdr-extension-with-michelle-lott#t=97) Distinction Between Delay and Extension
- [4:57](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-25-069-eu-mdr-extension-with-michelle-lott#t=297) Pathway 1: Competent Authority Submission
- [11:30](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-25-069-eu-mdr-extension-with-michelle-lott#t=690) Pathway 2: Notified Body Derogation
- [14:28](https://hardwarepodcasts.com/podcast/lets-combinate/2023-01-25-069-eu-mdr-extension-with-michelle-lott#t=868) Notified Body Selection and Industry Advice

## Topics

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

## Most relevant to

established companies

## Mentioned

- EU MDR (other)
- leanRAQA (company)
- MDCG (other)
- RAQA Today (other)

## Related episodes from other shows

- [Challenges for Regulatory Submission: EU vs. US](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-05-06-challenges-for-regulatory-submission-eu-vs-us) (Global Medical Device Podcast)
- [How does EU MDR impact your Quality Management System?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-22-how-does-eu-mdr-impact-your-quality-management-system) (Global Medical Device Podcast)
- [Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near) (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)
- [Assessing the Global Regulatory Landscape](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape) (Global Medical Device Podcast)

## Citing this page

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