Post-Brexit UK legislation for Medical Devices
What you need to do to place your device on the Great Britain, Northern Ireland and UK markets.
The MHRA is responsible for regulating medical devices in the UK market including:
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. For Northern Ireland, different rules apply to those in Great Britain.
Since 1 January 2021, there have been numerous changes, introduced through secondary legislation, to how medical devices are placed on the market in UK.
This white paper provides you a summary of key requirements for placing a device in UK market.