Device Sponsors Should Be Aware of Variations in EU, US Systems

Sponsors of implantable and Class III medical devices are required to conduct trials in the EU only when existing clinical data is insufficient to verify a device’s safety and performance. Contrary to the U.S. system, which requires clinical trials for all high-risk devices, the EU permits certification based on available clinical data that demonstrates safety and efficacy, Christiana Spontoni, European partner with Squire, Sanders & Dempsey, said. Also in the EU, clinical evaluation is done continuously for a device, both before and after certification, she said.
Clinical Trials Advisor