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
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
How to conform with the legal requirements for placing medical devices on the market.
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
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 and requires JavaScript).