Richard Horton (Jan 21, p 204) is right that device regulation in the UK is insufficiently robust and does not guarantee patient safety. I share the concern that, unlike the rigorous regulatory system in place for drugs, the assessment and regulation of medical devices is failing patients. Provided a device gains a CE mark from one of the 70 or more Notified Bodies (who do not necessarily require clinical trial data), it can be implanted in patients with no mandatory need by clinicians to keep an audit trail of device failures or complications. The barrier to entry is too low and independent surveillance too weak.
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