1 Meddev Solutions Limited (RAPS e-Book version)
Welcome Chapter 1
WELCOME
Welcome to this practical guide to implementing the EU IVDR.
This guidebook is all about the brand new European regulation and how to apply the requirements
into your business. This is part of the Meddev Solutions Guidebook Series, which provides practical tools and
guidance for In Vitro Diagnostic Device manufacturers and anyone else with a need to understand exactly
how to implement the IVDR.
This book is a reference guide, and as such, is not designed to be read from cover to cover. It is broken
into sections that can be quickly navigated through, giving reference to the original IVDR text, and what
requirements must be met. However, it does not replace the IVDR text, which should be used in conjunction
with this guidebook.
We hope you find this guidebook extremely useful and we will be updating the book as things move
forward and new versions of the regulation or additions are made.
Please note, the official IVDR text is the law and this guidebook should not be used to replace or modify the intention of
the law.
From the Meddev Solutions team
CHAPTER 1
Welcome Chapter 1
WELCOME
Welcome to this practical guide to implementing the EU IVDR.
This guidebook is all about the brand new European regulation and how to apply the requirements
into your business. This is part of the Meddev Solutions Guidebook Series, which provides practical tools and
guidance for In Vitro Diagnostic Device manufacturers and anyone else with a need to understand exactly
how to implement the IVDR.
This book is a reference guide, and as such, is not designed to be read from cover to cover. It is broken
into sections that can be quickly navigated through, giving reference to the original IVDR text, and what
requirements must be met. However, it does not replace the IVDR text, which should be used in conjunction
with this guidebook.
We hope you find this guidebook extremely useful and we will be updating the book as things move
forward and new versions of the regulation or additions are made.
Please note, the official IVDR text is the law and this guidebook should not be used to replace or modify the intention of
the law.
From the Meddev Solutions team
CHAPTER 1