Regulatory Approvals of Medical Devices in the EU vs the US: Quicker and Worse?


Submitted on Mon, 10/03/2016 - 12:06

A recent study by TJ Hwang et al (published online in the BMJ last August) suggests that medical devices first approved in the European Union (EU) are associated with increased risks of post-marketing safety alerts and recalls when compare with those first approved by the FDA in the United States.

The study looked at cardiovascular, orthopedic, and neurologic devices receiving CE Mark approval in the EU between 2005 and 2010. The investigators searched public and commercial databases up to January 2016 for press releases of approvals; public US Food and Drug Administration and European regulatory authority databases for approvals, safety alerts, and recalls; and Medline, Embase, and Web of Science for peer-reviewed publications. The investigators categorized the novelty of the devices in the study sample as a “major innovation” or “other change” and gleaned data about the devices and any safety alerts and withdrawals information. Cox proportional hazards regression models were used to evaluate factors associated with safety alerts and recalls and the publication of trial outcomes for devices categorized as major innovations.

The investigators found that 67% (206/309) of devices identified were approved in both the United States and the EU, of which 63% (129/206) were approved first in Europe. The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices first approved in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval) for devices first approved in Europe.