Aesthetic device scandal threatens to bring whole industry down with it
This article was originally published in Clinica
Executive Summary
Many products used for aesthetic purposes involve implantation, injection or piercing of the skin. In theory, they come under the medical device definition of causing modification to the anatomy or to a physiological process. Yet most of these products seem to fall into a regulatory no-man’s land. In this investigative feature, Amanda Maxwell exposes a bureaucratic loophole which allows unregulated copies of CE-marked medical devices, or the non-medical use of CE-marked equivalents, to enter the market unchecked