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

 
• By Eliza Slawther

There are growing fears that the new EU medtech regulations could result in products used for children or rare diseases vanishing from the market. In an interview with Medtech Insight, regulatory expert Tom Melvin explains how these devices can be protected.

Child Stethoscope
• Source: Shutterstock

“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...

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