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:
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.