EU MDR

EU Medical Device Regulation (EU MDR) – Chapters 1 to 5

The objective of this course is to provide you with an overview of the EU MDR 2017/745. This overview will guide you through the following the background of the EU MDR, why it was introduced, the EU MDR structure and timeline, the main differences between MDD and MDR, an overview of each chapter and some of the key challenges facing organizations due to its introduction. It is designed to provide the student with a high-level comprehension of the regulation and what it means for organizations in today’s world of medical device manufacture.

CEU Credits: 0.1

Course Code: ELM-327

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview Introduction

Learning Objectives for this Overview

The Background of the EU MDR 2017/745

1901 - Jim the Horse Tetanus Scandal

1959 - Primodos

1996 - ISO 13485 Medical Devices -- Quality Management Systems

2018 – Vaginal Mesh Implants

A Regulatory Evolution

Introduction to EU MDR

The Regulation

Chapters and Articles

Annexes

The EU MDR Timeline

What this means

MDD vs MDR

Chapters I to V

Chapter I

In Scope

Out of Scope

Definitions

Chapter II

Placing on the market and putting into service

Claims

Common Specifications

General obligations of Manufacturers

Authorized Representative

General obligations of Importers

General obligations of Distributors

Person Responsible for Regulatory Compliance (PRRC)

Chapter III

Medical Devices Nomenclature

European Database

Registration of Devices

Unique Device Identification System

Chapter IV

Authorities Responsible for Notified Bodies

Requirements Relating to Notified Bodies

Assessment of Application

Chapter V

Classification of Devices

Assessment of Conformity

Certificate of Sale

Conclusion

Final Assessment

Certification

Author

Ian Nicholls

Director at Explic8

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