# Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-05-07
- Length: 38m
- Episode: 202
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry
- Listen: https://podcast.greenlight.guru/episode/why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry

## Summary

Joanne LeBrun, VP of Quality Systems at MDC Associates, discusses the widespread anxiety surrounding the EU In-vitro Diagnostics Regulation (IVDR) deadline in May 2022. She explains that the industry faces a critical shortage of designated notified bodies, many of which are overwhelmed or choosing not to pursue IVDR designation due to the high cost and complexity compared to the EU MDR. LeBrun advises companies to immediately apply with existing notified bodies, update their technical documentation to avoid compliance failures, and understand the distinction between ISO certification and CE marking.

## Chapters

- [2:01](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry#t=121) The Notified Body Shortage and IVDR Readiness
- [4:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry#t=285) IVDR vs. MDR Implementation Challenges
- [7:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry#t=474) CE Mark Extensions and Self-Certification Cutoffs
- [12:22](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry#t=742) Applying to Notified Bodies and Product Codes
- [14:31](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry#t=871) MDC Associates Services and Greenlight Guru Platform
- [17:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry#t=1055) ISO Certification vs. Notified Body Roles
- [22:20](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry#t=1340) Technical File Maintenance and Compliance Risks
- [27:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry#t=1678) Risk Management Standards and Final Advice

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

established companies

## Mentioned

- MDC Associates (company)
- Greenlight Guru (company)
- IVDR (other)
- EU MDR (other)
- ISO 13485 (other)
- ISO 14971 (other)
- NANDO (other)
- FDA (company)

## 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)
- [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)
- [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)
- [060 - Why People Leave, Starting Elemed and Trusted Advisory with Elena Kyria](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-23-060-why-people-leave-starting-elemed-and-trusted-advisory-with-elena-kyria) (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/2021-05-07-why-is-ivdr-causing-widespread-panic-throughout-the-medical-device-industry. 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.