Regulating Medical Devices in the UK is slightly different to other countries. When manufacturing medical devices for the UK market, you must be registered with the MHRA. They can help to ensure that your device meets safety guidelines and issue you with advice should you need it.
Regulating medical devices in the UK Read More »
In the UK Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.
Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.
Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the UK market.
Medical Devices Classification UK Read More »
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