# Preparing for EU MDR

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2019-11-26
- Length: 30m
- Episode: 124
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-preparing-for-eu-mdr
- Listen: https://podcast.greenlight.guru/episode/preparing-for-eu-mdr

## Summary

Isabella Schmitt, a regulatory affairs consultant at Proxima Clinical Research, explains how medical device companies can prepare for the EU MDR, which was set to take effect in May 2020. She details the shift from the old Medical Device Directive (MDD) to the new regulation, emphasizing the need for comprehensive lifecycle safety data and the difficulties of establishing device equivalency. Schmitt advises companies to conduct gap analyses of their General Safety and Performance Requirements (GSPRs) and notes that many firms are using FDA pre-submission meetings to guide their EU clinical strategies.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-preparing-for-eu-mdr#t=0) Introduction and Proxima Clinical Research Overview
- [6:16](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-preparing-for-eu-mdr#t=376) EU MDR Context and the PIP Implant Debacle
- [8:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-preparing-for-eu-mdr#t=487) Equivalency and Clinical Data Burdens
- [10:59](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-preparing-for-eu-mdr#t=659) Gap Analysis for Established and New Products
- [13:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-preparing-for-eu-mdr#t=810) Using FDA Pre-Subs for EU Strategy
- [20:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-preparing-for-eu-mdr#t=1210) Notified Bodies and Market Access Challenges
- [23:52](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2019-11-26-preparing-for-eu-mdr#t=1432) EUDAMED Database and Clinical Harmonization

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)

## Most relevant to

early-stage companies

## Mentioned

- Proxima Clinical Research (company)
- Greenlight Guru (company)
- EUDAMED (other)
- FDA (other)
- MD Anderson (company)
- Houston Methodist (company)
- Memorial Hermann (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)
- [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)
- [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)
- [051 - "EU MDR" with Bassil Akra](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra) (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/2019-11-26-preparing-for-eu-mdr. 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.