The Medical Device Regulation (MDR 2017/745) compliance takes effect in less than one year, meaning big impending changes for how medtech companies run their post-market surveillance and vigilance programs. What are the industry implications? In practical terms this means: 

• Many legacy products will need to be recertified
• Many devices will be reclassified as higher risk 
• And devices in development will be held to a more rigorous approval process