# Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2020-12-17
- Length: 31m
- Episode: 172
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near
- Listen: https://podcast.greenlight.guru/episode/tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near

## Summary

Bassil Akra, CEO and Co-Owner of QUNIQUE Group, explains the critical challenges medical device companies face in transitioning to EU MDR and IVDR, highlighting the severe bottleneck of notified body capacity and the increased burden of clinical evidence requirements. He clarifies that holding a valid MDD certificate does not buy significant time, as manufacturers must still meet MDR post-market surveillance and vigilance obligations immediately, with full certification required by mid-2023. Akra warns that the IVDR transition is particularly dangerous for the industry because 80-90% of the market will suddenly require notified body involvement, creating a resource gap that existing infrastructure cannot fill. He advises companies to read the regulations, re-evaluate notified body capacity, and manage strict implementation timelines to avoid losing market access.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near#t=0) Introduction: Jon Speer and Bassil Akra on EU MDR/IVDR Readiness
- [2:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near#t=170) Notified Body Capacity and the Impact of COVID-19
- [6:57](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near#t=417) Regulatory Uncertainty, EUDAMED, and Clinical Evidence Requirements
- [11:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near#t=716) Clarifying the MDD Grace Period and MDR Transition Obligations
- [15:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near#t=941) QUNIQUE Group Services and MDSAP Support
- [18:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near#t=1122) The IVDR Crisis: 80-90% Market Shift to Notified Body Oversight
- [25:48](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near#t=1548) Actionable Tips: Read Regulations, Select Notified Bodies, and Manage Timelines

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Scaling production](https://hardwarepodcasts.com/topic/scaling-production)
- [Starting a product company](https://hardwarepodcasts.com/topic/starting-a-company)

## Most relevant to

early-stage companies

## Mentioned

- QUNIQUE Group (company)
- Greenlight Guru (company)
- EUDAMED (other)
- MDSAP (other)
- ISO 14971 (other)

## Related episodes from other shows

- [051 - "EU MDR" with Bassil Akra](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra) (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)
- [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)
- [099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi) (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/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near. 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.