Does Europe offer faster, better approach than FDA on medical devices?

The medical device industry is touting a study it says debunks the Food & Drug Administration’s claims that there’s a safety benefit from the slower, more rigorous regulatory process in the U.S.

The conclusions are based on a new study, paid for by the Advanced Medical Technology Assn., that compares four years of recall data from U.S. and EU regulatory bodies.

The study, “EU Medical Device Approval Safety Assessment,” conducted by the Boston Consulting Group, matched four years of medical device recall data for the United Kingdom, Germany, Switzerland and Ireland and compared it with similar U.S. data. The report’s authors conclude that there is no material difference between the regulatory regimes in the U.S. and Europe, from a safety perspective.

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