# 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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2024-01-24
- Length: 43m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/120---EU-MDR-RR-Whats-the-difference-between-Legal-Manufacturer--Authorized-Rep--PRRC--Importer-and-Distributor--with-Founder-of-Easy-Medical-Device--Monir-El-Azzouzi-e2erhnk

## Summary

Monir El Azzouzi, founder of Easy Medical Device, explains the distinct roles of legal manufacturer, authorized representative, importer, and distributor under the EU Medical Device Regulation (MDR). He details how these economic operators share liability for product compliance, with authorized representatives and importers performing specific verification checks on technical documentation and labeling before products enter the market. El Azzouzi emphasizes that while distributors handle physical logistics, importers and authorized reps are responsible for regulatory clearance, including maintaining traceability through UDI and EUDAMED database registrations. The conversation highlights the critical importance of clear mandates, quality agreements, and the legal obligation for authorized representatives to terminate contracts with non-compliant manufacturers to avoid personal liability.

## Chapters

- [0:03](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr#t=3) Introduction: Subhi Sade and Monir El Azzouzi
- [1:56](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr#t=116) The Economic Operator Model and Liability
- [7:56](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr#t=476) Legal Manufacturer and Authorized Representative Roles
- [23:10](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr#t=1390) Authorized Representative Responsibilities and PRRC
- [26:14](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr#t=1574) Importers, Distributors, and Supply Chain Ownership
- [27:38](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr#t=1658) Traceability, Documentation, and Independent Importers
- [36:34](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr#t=2194) Terminating Mandates and Regulatory Compliance
- [40:54](https://hardwarepodcasts.com/podcast/lets-combinate/2024-01-24-120-eu-mdr-r-r-whats-the-difference-between-legal-manufacturer-authorized-rep-pr#t=2454) Easy Medical Device Services and Community

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Sourcing & supply chain](https://hardwarepodcasts.com/topic/sourcing-and-supply-chain)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)

## Most relevant to

early-stage companies

## Mentioned

- Easy Medical Device (company)
- EU MDR (other)
- EUDAMED (other)
- ISO 13485 (other)
- BfArM (other)

## Related episodes from other shows

- [Explaining the Role of Importer under EU MDR](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-01-explaining-the-role-of-importer-under-eu-mdr) (Global Medical Device Podcast)
- [How does EU MDR impact your Quality Management System?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-22-how-does-eu-mdr-impact-your-quality-management-system) (Global Medical Device Podcast)
- [#339: UDI and the State of EUDAMED](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-12-339-udi-and-the-state-of-eudamed) (Global Medical Device Podcast)
- [Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-12-17-tips-to-prepare-for-eu-mdr-and-ivdr-as-deadlines-draw-near) (Global Medical Device Podcast)
- [Assessing the Global Regulatory Landscape](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-10-21-assessing-the-global-regulatory-landscape) (Global Medical Device Podcast)

## Citing this page

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