The EU Medical Device Regulation Guidebook
The compliance guide is the starting point to aid compliance with the MDR. It provides an overview to the requirements of the MDR and helps a manufacturer build the documentation required to demonstrate compliance.
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 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.
What’s Included?
- Welcome
- 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
The EU Medical Device Regulation Guidebook
Providng you with an overview of the requirements of MDR so you can demonstrate compliance confidently.
€255