Medical devices face tougher premarket testing under new EU laws

BMJ 2017; 357: j1870
Author: Deborah Cohen
“The European Parliament has passed new legislation to tighten regulation of medical devices that will require high risk devices, such as hip implants, to undergo more premarket testing and assessment. European device regulation has come in for criticism after a series of high profile failures—including hip replacements, breast implants, and pelvic meshes—that have resulted in harm to patients.”
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