# Systematic Literature Review for EU MDR

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-04-05
- Length: 38m
- Episode: 313
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr
- Listen: https://podcast.greenlight.guru/episode/systematic-literature-review-for-eu-mdr

## Summary

Ethan Drower, Co-Founder and Operating Partner of CiteMed, explains the rigorous process of conducting systematic literature reviews for EU MDR Clinical Evaluation Reporting (CERs). He details how the EU MDR has shifted scrutiny from equivalence to empirical data, requiring manufacturers to search multiple databases like PubMed and Embase to prove device safety. Drower highlights common pitfalls, such as starting too late and failing to maintain continuous post-market surveillance, while advocating for software tools to manage the volume of clinical data.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr#t=0) Introduction: Ethan Drower and CiteMed
- [3:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr#t=225) EU MDR vs FDA 510(k): The Shift to Empirical Data
- [8:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr#t=507) The CER Process: Literature Review and Compilation
- [10:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr#t=612) Data Sources: PubMed, Embase, and Cochrane Library
- [12:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr#t=762) Qualifying Reviewers: Experience vs. Degrees
- [14:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr#t=857) CiteMed's Origin: Software for Regulatory Pain Points
- [18:46](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr#t=1126) Common Pitfalls: Timing and Search Thoroughness
- [25:44](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr#t=1544) Post-Market Surveillance and Continuous Updates
- [29:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-04-05-systematic-literature-review-for-eu-mdr#t=1773) Notified Body Backlogs and Submission Strategy

## Topics

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

## Most relevant to

early-stage companies

## Mentioned

- CiteMed (company)
- Greenlight Guru (company)
- PubMed (other)
- Embase (other)
- Cochrane Library (other)
- clinicaltrials.gov (other)
- EU MDR (other)
- FDA (other)

## Related episodes from other shows

- [059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower) (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)
- [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)
- [054 - "EUDAMED" with Richard Houlihan](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan) (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/2023-04-05-systematic-literature-review-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.