# Explaining the Role of Importer under EU MDR

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-07-01
- Length: 34m
- Episode: 217
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr
- Listen: https://podcast.greenlight.guru/episode/explaining-the-role-of-importer-under-eu-mdr

## Summary

René Van De Zande, partner at MedEnvoy Global and former CEO of EMERGO by UL, explains the critical role of importers under the EU Medical Device Regulation (EU MDR). He details how importers and distributors share overlapping obligations under Articles 13 and 14, requiring robust quality management systems and due diligence to ensure device compliance, traceability, and proper labeling. Van De Zande highlights the operational challenges of managing multiple distributors as de facto importers and the necessity of independent importer services to maintain supply chain control. The discussion also covers regulatory nuances in the UK post-Brexit and Switzerland following the loss of the Mutual Recognition Agreement.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr#t=0) Introduction: Jon Speer and René Van De Zande on EU MDR Importer Roles
- [2:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr#t=131) Economic Operators and the Critical Role of the Importer under Article 13
- [4:56](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr#t=296) Distributor Classifications and Supply Chain Mapping
- [10:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr#t=621) Pre-MDR vs. MDR: Designating Importers and Quality Agreements
- [12:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr#t=769) Due Diligence, Audits, and Quality Management Systems for Importers
- [17:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr#t=1049) MedEnvoy Global: Independent Importer Services and Company Background
- [21:39](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr#t=1299) PRRC vs. Importer: Distinct Roles and Whistleblower Protections
- [28:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr#t=1688) Managing Multiple Distributors and Labeling Identification
- [30:50](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr#t=1850) UK Post-Brexit and Swiss Regulatory Requirements

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Direct-to-consumer & e-commerce](https://hardwarepodcasts.com/topic/direct-to-consumer)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

early-stage companies

## Mentioned

- MedEnvoy Global (company)
- EMERGO by UL (company)
- Greenlight Guru (company)
- EU MDR (other)
- ISO 13485 (other)
- UK (other)
- Switzerland (other)

## Related episodes from other shows

- [120 - EU MDR R&R: What's the difference between Legal Manufacturer, Authorized Rep, PRRC, Importer and Distributor? with Founder of Easy Medical Device, Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr) (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)
- [051 - "EU MDR" with Bassil Akra](https://hardwarepodcasts.com/podcast/lets-combinate/2022-09-21-051-eu-mdr-with-bassil-akra) (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)
- [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/2021-07-01-explaining-the-role-of-importer-under-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.