In the EU, many medical devices can be approved without clinical testing, which speeds the rate of approval. This has stirred controversy and incited calls for regulatory reform in both the EU and U.S.
For the study, a team of researchers from the United Kingdom and the U.S. searched public and commercial databases to analyze safety issues linked to medical devices approved in the U.S. and the EU.
Researchers identified 309 devices approved between 2005 and 2010, and 206 of them were approved by both the EU and the U.S. The majority of those (63 percent) were approved first by the EU.
Overall, roughly a quarter (75 of 309) of the devices were associated with safety issues after they went to market. The devices first approved in the EU were associated with a rate of safety alerts and recalls nearly three times greater than those first approved by the U.S.
The authors concluded, “Our findings suggest that products introduced earlier in their development cycle are also more likely to increase the risk of harms, underscoring the urgent need for transparency to make truly informed decisions.”
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