Safety and industry 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 the U.S., according to the report, prepared by The Boston Consulting Group (BCG) for AdvaMed. “We found the same number of recalls, even though the belief is there are more devices out in Europe,” Simon Goodall, BCG partner and managing director, said during a conference call in late January.

However, safety advocates said the disclosed hurdles in conducting the study are evidence that the claim that recall rates are equal in both the EU and the U.S. should be viewed with skepticism.
The GMP Letter