Jan 28, 2011

A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.

Conducted by Boston Consulting Group, the study analyzed public data pertaining to severe recalls in European markets, finding that the number of European recalls equaled that of Class I recalls in the US. Researchers contend that these comparable recall rates shows that Europe’s faster approval process for medical devices does not compromise public safety. The study contextualizes its findings within the emerging trend of Europe becoming the first choice for manufacturers seeking product approval, as well as ongoing deliberations by the FDA regarding whether to make its 510(k) clearing process more rigorous. The study’s results fall rather neatly in line with AdvaMed’s longstanding objections to a stricter regulatory approach by the FDA, and an analysis by MassDevice notes difficulties—disclosed by Boston Consulting Group as well—study conductors had in obtaining a clear comparison of recall data between the two regulatory regimes given the decentralized EU system. Grain-of-salt caveats aside, though, the study results provide further indication that time-insensitive medical device review processes can have serious implications in terms of where innovative manufacturers choose to bring their products to market.


  • Stewart Eisenhart