Regulating medical devices in the UK

What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

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.

External link:

https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk