# Assessing the Global Regulatory Landscape

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-10-21
- Length: 24m
- Episode: 232
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape
- Listen: https://podcast.greenlight.guru/episode/assessing-the-global-regulatory-landscape

## Summary

Adnan Ashfaq, founder of Simplimedica, discusses the rocky transition to the EU Medical Device Regulation (MDR) and the upcoming In Vitro Diagnostic Regulation (IVDR) with host John Spear of Greenlight Guru. Ashfaq highlights that while MDR was delayed due to COVID-19, many companies are still ignoring the mandate, risking their business viability. He warns that IVDR poses even greater challenges due to a shortage of notified bodies and the requirement for external reference laboratories for high-risk devices.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape#t=0) Introduction and Guest Background
- [2:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape#t=133) The MDR Transition Landscape
- [4:34](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape#t=274) Company Priorities and Notified Body Constraints
- [8:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape#t=488) Strategic Shifts and Software Definitions
- [9:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape#t=576) Simplimedica Services and Regulatory Guidance
- [12:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape#t=728) Implementation Advice and Brexit Impacts
- [19:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape#t=1147) IVDR Challenges and Classification Changes
- [22:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape#t=1323) Final Advice on Hiring and Resources

## 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

companies scaling up

## Mentioned

- Simplimedica (company)
- Greenlight Guru (company)
- EU MDR (other)
- IVDR (other)
- EUDAMED (other)
- MDCG (other)
- RWS (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)
- [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)
- [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)

## 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/2021-10-21-assessing-the-global-regulatory-landscape. 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.