The European Medical Device Regulation (2021 Update)

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The European Medical Device Regulation (2021 Update)
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>> How to Use This Guidebook

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. It 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
And now it just got better!

When the Guidebook was written in 2018, there was no published guidance, there were no manufacturers with CE-marked devices against the new regulation, and not a single notified body had been designated. Fast forward on to early 2021 and what a difference! Currently, there are 19 designated notified bodies, many devices have been successfully CE-marked under the new regulation, and there are more than 50 guidance documents. Due to the significance of these changes, the Guidebook soon will be updated to reflect the current understanding of the EU MDR and the second edition will be released.

In the meantime, we have created an electronic supplement to the first edition that details the changes and will help you stay informed on this crucial regulation until the second edition can be published. The e-supplement provides a summary of the changes and includes important extra information.

Important note: By purchasing this product, you are purchasing a bundle which includes a paperback copy of The European Medical Device Regulation as well as an e-book copy of the 2021 E-book Supplement referenced above. Both products can also be purchased separately. 

This bundle can also be purchased in an all electronic format.

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