A French parliamentary commission of inquiry is calling for sweeping reforms of medical devices regulation in France and across Europe, branding the current system “massively dysfunctional.”
In a blistering 97-page report endorsed on March 6, the Specially Convened Commission on Medical Devices advocated 36 separate reforms, including the creation of a centralized European agency to approve high-risk devices before sale and the establishment of a laboratory to investigate implants after they have been extracted – many of them after failing.
source International Consortium of Investigative Journalists
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