Clue to UK's new regulatory requirements - approval of all devices placed on the market?

dgrainger

dgrainger

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Yesterday saw the publication of the UK's Independent Medicines and Medical Devices Safety Review:

the Independent Medicines and Medical Devices safety Review - Oral hearings

In it is the following recommendation:

1.45 At present the MHRA has no involvement in the pre-market phase of medical​
device development. It should develop a proactive regulatory role for devices that is​
more akin to the licensing of medicines; this must be clinically focussed and at least​
as stringent as the new EU Medical Devices Regulations (MDR). The MHRA should​
keep a register of all devices approved for the UK market. Manufacturers should be​
required to apply to the MHRA before marketing their device. The MHRA should​
assess the application in a way that is proportionate to the risks posed taking into​
account relevant factors such as, the evidence base supplied, approvals in other​
jurisdictions, and the post-marketing surveillance plans. If approved a device will be​
added to the register. Marketing approval for devices should be a staged process,​
progressing to wider use and dissemination of the device as more information​
becomes available. In the event of an issue with a device the MHRA must have the​
power to remove a device from the register. Given there are an estimated 600,000​
or more devices on the market we recognise that initially this will almost certainly​
involve some ‘grandfathering’ of currently marketed devices.​
 
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