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external identifier
207290
UK Government and Parliament Id
207290
e-petition UK Government and Parliament Id
207290
action
Introduce proper effective regulation of implantable medical devices
background
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
additional details
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
created at
2017-12-07T17:06:38.779000+00:00
updated at
2019-03-14T10:42:05.712000+00:00
closed at
2018-06-15T22:59:59.999000+00:00
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