Regulating Medical Devices in the UK

On 1 January 2022 the MHRA updated this guidance to reflect changes to the new medical device regulatory requirements.

This guidance provides information on the UK system, including for:

getting your device certified
conformity marking your device
registering your device with the MHRA

This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.