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Study reveals differing standards for approval of American, European medical devices

Jun 29, 2016 | Katherine Davis

Medical devices play a vital role in patient care, but how they are approved and regulated are vastly different in the United States compared to the European Union.

A new study, published today in the BMJ, revealed that those differences actually matter. The study found devices approved in the EU first are associated with a greater rate of safety issues than those initially approved in the U.S.

As a result of the findings, the researchers are now calling for greater regulatory transparency to ensure patients and providers are making informed decisions about treatment when choosing a medical device to use.

In the EU, testing standards are different than in the U.S. For example, devices can be approved if they perform “as intended” and are likely to be safe, according to BMJ. In most cases, clinical testing is only required for some high-risk devices. However, in the U.S., all high-risk devices must demonstrate reasonable safety and effectiveness in clinical trials before they can be approved.

To find data, the researchers searched public and commercial databases for announcements about new medical devices approved in the EU between 2005 and 2010 and found a total of 309 devices. Of the 309 devices, 206 were approved in both the U.S. and the EU, but 63 percent of them were approved in the EU first. Devices approved in the EU first were associated with nearly three times the likelihood of being tagged with a safety alert or being recalled.

“Patients and clinicians need access to, and balanced presentation of, the available evidence of the safety and effectiveness of novel devices, as well as clear communication about the evidentiary gaps,” the researchers wrote in the study. “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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