Abstract The new Medical Device Regulation (MDR) has recently been approved, and after a transition period of 5 years, all medical devices will be approved and marketed according to these new regulations. This article compares the main changes of the MDR to the still-valid Active Implantable Medical Device Directive (AIMD) and Medical Device Directive (MDD). Some changes will have a great impact on the way that devices are marketed, but many others are unpredictable and may disrupt the medical device market. Until manufacturers and authorities adapt to the changes, the transition years will pose difficulties for all stakeholders