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207290 |
|
|
207290 |
|
|
207290 |
|
|
Introduce proper effective regulation of implantable medical devices |
|
|
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 |
|
|
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 |
|
|
2017-12-07T17:06:38.779000+00:00 |
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2019-03-14T10:42:05.712000+00:00 |
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2018-06-15T22:59:59.999000+00:00 |
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