Let's Combinate - Drugs + Devices24 Tammi 2024

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

In this special episode of the comedy podcast, host Subhi Sade welcomes Munir Al Azouzi, the founder of Easy Medical Device.

Munir shares his expertise on the often confusing topic of the EU’s Medical Device Regulation (EUMDR), focusing on the distinctions between roles such as legal manufacturer, distributors, importers, authorized reps, and persons responsible for regulatory compliance.

Munir explains the need for compliance checks, supply chain management, traceability documentation, and regulatory responsibilities in the context of the EUMDR. He also discusses his company's role as an authorized representative, importer, and consultant, and the various services they offer to help medical device manufacturers navigate regulatory complexities.

00:03 Introduction and Guest Introduction

01:47 Understanding the Economic Operator Model

07:56 Legal Manufacturer

09:41 The Role of the Authorized Representative and PRRC

23:39 Understanding the Role and Responsibility of Authorized Representatives

26:14 The Role of Importers and Distributors

27:38 The Importance of Traceability in the Supply Chain

38:14 Terminating a Mandate with a Manufacturer

40:55 Conclusion and Easy Medical Device

Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, podcasts, online courses.

Easymedicaldevice.com

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