The EU Medical Device Regulation Guidebook

If you are involved in ensuring compliance with the EU MDR, the Meddev Solutions MDR Guidebook will be your ‘go-to’ reference and tool kit, intended to be your companion to reference time and time again. eBook available through RAPS.
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The must-have guide for MDR implementation 

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440 Pages

14 Chapters

Only €255

When the original guidebook was written back in 2018, there had been no published guidance, there were no manufacturers that had CE marked devices against the EU MDR and not a single notified body had been designated. Fast forward on to now and what a difference! At the time of writing this, we now have 19 designated notified bodies, many devices have been successfully been CE marked under the regulation and there are over 50 guidance documents.  ⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀⠀

Due to all of these changes, we needed to update our guidebook to reflect the current understanding of the EU MDR, bringing you the 2nd edition of the EU MDR Guidebook. This Guidebook is a reference guide and as such, is not designed to be read 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. ​

This book is part of the Meddev Solutions’ Guidebook Series, offering practical application guidance to a number of topics that are important for device manufacturers to understand.

Guidebook Content

Background to the MDR
QMS tables 
Compliance guide 
SPR & Risk checklists
Process table
Timelines (Tabular & Visual)
Clinical Evaluation 
MDR Overview - Articles (1 - 123)
Maps (Annexes, Clinical, PMCF, PMS, Vigilance & NB's)
MDR Overview - Annexes 
People in the MDR
 Player roles
MDCG Guidance

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