The European Medical Device Regulation (2021 Update e-book)
Table of Contents
Chapter 1: Welcome
Chapter 2: Background to the MDR
Chapter 3: How to Use this Guidebook
Chapter 4: Compliance Guide
Chapter 5: Device Classification
Chapter 6: Clinical Evaluation
Chapter 7: Conformity Assessment Route & Annexes
Chapter 8: QMS Tables
Chapter 9: Timelines
Chapter 10: MDR Overview - Articles
Chapter 11: MDR Overview - Annexes
Chapter 12: Indexes & Look Ups
Chapter 13: People
Meddev Solutions, Publisher
About the Book
Available formats: print and e-book
RAPS has teamed up with Meddev Solutions to offer The European Medical Device Regulation Guidebook. For anyone involved in ensuring compliance with the EU MDR, it is the ‘go-to’ reference and tool kit, intended to be your companion to reference time and time again.
This Guidebook is a reference guide and as such, is not designed to be read cover to cover. It is broken into 11 colour coded chapters that can be quickly referenced to help navigate through the text of the MDR and to implement the requirements needed. The Guidebook contains a number of useful tools and tables to guide you through the EU MDR, such as:
- Device classification and their differences from the MDD
- QMS requirements and how they align with ISO 13485
- Technical documentation requirements
- Clinical data requirements, including a handy checklist
- General safety and performance requirements tables
- Annex and article guide
Key Features
- 11 colour coded chapters to aid navigation and allow for quick referencing of the MDR
- 7 practical tools to assist the implementation of the MDR requirements
- Take anywhere in the world with the handy e-book format, brought to you exclusively by RAPS
- Part of the Meddev Solutions Guidebook Series – Discover the IVDR Guidebook here
2021 Update
By purchasing this product, you are purchasing a bundle which includes an e-book copy of The European Medical Device Regulation as well as an e-book copy of the 2021 EU MDR E-book Supplement. This digital supplement provides a focused update to the original European Medical Device Regulations guidebook, reflecting changes that occurred after the first edition was published.
It summarizes key regulatory developments through Q1 2021, including the implementation of the EU MDR, the designation of notified bodies, successful CE markings under the regulation, and the publication of related guidance. Rather than republishing the full book, the supplement highlights what has changed between the first and second editions, allowing readers to easily reference updated information alongside the original text.
The supplement is intended to be used in conjunction with the The European Medical Device Regulation.
Purchasing Options
This bundle can be purchased in the following formats:
- Digital Guidebook + e-book supplement. Single purchase of the original e-guidebook and supplement; accessible online via RAPS Library online reader and downloadable.
- Printed Guidebook + e-book supplement. Single purchase of the printed guidebook; includes the electronic ebook supplement accessible online via RAPS Library online reader and downloadable.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
