1 Meddev Solutions Limited (RAPS e-Book version)
Welcome Chapter 1
WELCOME
Welcome to this practical guide to implementing the EU MDR.
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 medical device manufacturers and anyone else with a need to understand exactly how to implement the
MDR.
The 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 referenced to help navigate through the text of the MDR and to implement
the requirements needed. It doesn’t replace the MDR text, which should be used in conjunction with this
guidebook.
As this guidebook is not designed to be read from cover to cover, it is essential to understand how it works and
how it is used, so please make sure you read Chapter 3 -‘how to use this guidebook’
We hope you find this book extremely useful and we will be updating the book as things move forward, with
additions such as Common Specifications, as and when they appear. Please note, the official MDR text is the
law and this guidebook should not be used to replace or modify the intention of the law.
This is the first book in the Meddev Solutions Guidebook Series, we hope you find it useful!
Meddev Solutions Limited.
CHAPTER 1
Welcome Chapter 1
WELCOME
Welcome to this practical guide to implementing the EU MDR.
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 medical device manufacturers and anyone else with a need to understand exactly how to implement the
MDR.
The 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 referenced to help navigate through the text of the MDR and to implement
the requirements needed. It doesn’t replace the MDR text, which should be used in conjunction with this
guidebook.
As this guidebook is not designed to be read from cover to cover, it is essential to understand how it works and
how it is used, so please make sure you read Chapter 3 -‘how to use this guidebook’
We hope you find this book extremely useful and we will be updating the book as things move forward, with
additions such as Common Specifications, as and when they appear. Please note, the official MDR text is the
law and this guidebook should not be used to replace or modify the intention of the law.
This is the first book in the Meddev Solutions Guidebook Series, we hope you find it useful!
Meddev Solutions Limited.
CHAPTER 1