Physicians at this year’s European Society of Cardiology meeting in Paris called for an overhaul of Europe’s CE Mark medical device approval process, calling it too lax in review of potentially dangerous products.
Medical device makers have chided the FDA for inefficient review of new technologies and Congress has asked the watchdog agency to review Europe’s less stringent process for opportunities to revamp the system at home, but doctors had harsh criticism for the CE Mark pathway, saying it uses the same structure to review pacemakers and electric toasters.