Repeated scandals involving medical devices show that the current regulatory system is not fit for purpose Tighten regulation of medical devices so that: - High risk medical devices have clinical trial evidence at the time of approval - There is a publicly accessible registry for such devices
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There have been multiple scandals over implanted medical devices, including pacemakers, TVT meshes, breast implants, & metal hip joints.
Current rules mean manufacturers don't have to produce clinical trial evidence before CE safety marking & use in patients. Equivalence allows a new device to be waved through if a manufacturer declares it similar to an existing product, even if those other products have had safety concerns.
Reference: BMJ Open 2017;7:e017125
doi: 10.1136/bmjopen-2017-017125