How to prepare for the new European MDR and IVDR
A guide to understanding the new regulations, how they apply to you, and what your next steps should be.
In May 2017, the European Parliament and Council published a set of regulations for medical devices (MDR) and in-vitro diagnostics (IVDR) that will require manufacturers to make significant changes to the way they place their devices into the European market and how they maintain compliance throughout the product’s lifecycle.
These legislation updates are expected to be applied by May 2020 for medical devices and by May 2022 for in-vitro diagnostics, giving companies a limited time to deeply understand the changes and fully implement them to bring their organization into compliance. Companies not complying will not be able to sell medical devices and in-vitro diagnostics in the EU.
To learn more about this substantial overhaul, complete the form and download our guide.
This article will walk you through every aspect of the MDR and IVDR update, including:
- Major changes to the legislation
- Updates to device classifications
- How to tell if your products are affected
- Maintaining compliance with the update