Introduce proper effective regulation of implantable medical devices

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Introduce proper effective regulation of implantable medical devices

Petition Details

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 Information

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

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