Gone Are the Days of Europe-First Medical Device Innovation
For decades it was a widely accepted strategy to bring new medical devices to the European market first. Simply put, obtaining a CE mark was faster, cheaper, and more predictable than getting regulatory approval anywhere else. That speed-to-market, however, was often seen as a tradeoff for patient safety. Instead of pumping money into rigorous clinical trials to demonstrate the product’s safety and efficacy, medical devices could be sold in Europe…
