Experts are questioning a study that claims the device regulatory system in Europe is as safe as in the U.S., despite the EU’s reputation for putting devices in the market faster. The average number of serious recalls is about 21 per year in both Europe and America, according to the report, prepared by The Boston Consulting Group (BCG) for AdvaMed. However, safety advocates said the disclosed hurdles in conducting the study are evidence that the claim should be viewed with skepticism. “They present no data to justify this assumption except to note conversations they had with EU regulatory officials,” Sidney Wolfe, director of Public Citizen’s Health Research Group, says.
Devices & Diagnostics Letter