Petition · past parliament
Introduce proper effective regulation of implantable medical devices
Closed
2,060 signatures
What the petition asks
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
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
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
Timeline
| 15 Dec 2017 | Petition opened for signatures |
| 15 Jun 2018 | Closed to new signatures |
Key facts
Signatures
2,060
Status
Closed
Opened
15 Dec 2017
Closed
15 Jun 2018
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Source: the official petition page. Last checked 15 Jul 2026.