EU Medical Device Regulation (MDR)

The Medical Device Directive (MDD) was replaced by the Medical Device Regulation (MDR 2017/745) in May 2021. Medical devices with a valid MDD EC Notified Body certificate may during a transition period still be placed on the market until May 2024.

The new regulation will have a great impact on all medical device actors, throughout the lifecycle of the devices, with stricter requirements on both products and on manufacturers’ Quality Management Systems.

In this course you will get a basic understanding of the new requirements to help you prioritize and succeed with the MDR transfer.