Overview:
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.
Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland.
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.
This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.
Summary of key requirements for placing a device on the Great Britain market:
Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales and Scotland). These are:
- a new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the Great Britain market
- all medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market
- if you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration. Further detail on the UK Responsible Person is set out below
- CE marking will continue to be recognised in Great Britain until 30 June 2023
- certificates issued by EU-recognised Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
- the EU no longer recognises UK Notified Bodies
- UK Notified Bodies are not able to issue CE certificates - and have become UK Approved Bodies
The role of the MHRA:
The MHRA performs market surveillance of medical devices on the UK market and is able to take decisions over the marketing and supply of devices in the UK.
The MHRA is responsible for the designation and monitoring of UK conformity assessment bodies.
MHRA Regulating medical devices in the UK: Overview: