Define, Identify And Protect: How EU Regulators Can Prevent Device Shortages

“Define, identify and provide solutions” would be the mission statement of Tom Melvin, associate professor of Medical Device Regulatory Affairs at Trinity College, Dublin, Ireland, if he were tasked with preventing vulnerable medical devices from disappearing from the market in the EU.

While capacity bottlenecks, high costs for manufacturers and lengthy assessment times as a result of the EU Medical Device Regulation are set to impact a wide range of medical devices, Melvin’s focus