Regulating Medical Devices & Place on The Market – UK

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

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

1. getting your device certified

2. conformity marking your device

3. registering your device with the MHRA

MHRA updated 2 guidance’s

1. Regulating medical devices in the UK

2. Register medical devices to place on the market

In order to know what you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets click here. In this guidance, “medical device” includes in vitro diagnostic medical devices and active implantable medical devices. This guidance only applies to medical devices and does not cover other CE or UKCA marked products, which are subject to separate guidance.

In order to know how to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland click here. All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland).