We use some essential cookies to make this website work.
We’d like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services.
We also use cookies set by other sites to help us deliver content from their services.
You have accepted additional cookies. You can change your cookie settings at any time.
You have rejected additional cookies. You can change your cookie settings at any time.
Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
Background In 2021, the U.S. Food and Drug Administration (FDA), Health…
Information on MHRA's enforcement duties and how to report a non-compliant medical device.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
How to conform with the legal requirements for placing medical devices on the market.
Information on when software applications are considered to be a medical device and how they are regulated.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Information and guidance on a range of medical devices for users and patients.
Information about the EU Regulations and their implementation in Northern Ireland
Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices
Advice on writing clear notices and maximising replies to your FSNs.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Information for clinicians and patients.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Guidance on what approved bodies are, what they do and how you can become one.
Don’t include personal or financial information like your National Insurance number or credit card details.
To help us improve GOV.UK, we’d like to know more about your visit today. Please fill in this survey (opens in a new tab).