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
Attributions of risk and blame in smart product failure.
Ensuring you get what you pay for.
Independent research report.
Why it's important to evaluate digital health products that have been developed rapidly and how to choose evaluation methods in these circumstances.
Find out which regulations apply to your products and where to go for further information on how to comply with them.
Guidance on choosing evaluation study types and methods.
What you need to do to comply with regulations on manufactured products you place on the market in Great Britain.
What you need to know about and do to comply with the law and keep consumers safe.
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.
The rules about product labelling - including special rules for retailers and manufacturers in different business sectors (like food, jewellery and toys)
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Product security factsheet accompanying the Product Security and Telecommunications Infrastructure Bill, outlining the problems the Bill will address and how.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Find out if you need to use the UKCA (UK Conformity Assessed) marking on products you manufacture or handle.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
If you're advertising or marketing, including direct marketing, you must be accurate and honest and follow the advertising codes of practice
How the MHRA makes decisions on what is a medicinal product (borderline products).
Find out what a composite food product is, and the rules you need to follow to export or move these products from Great Britain to the EU and Northern Ireland.
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. We’ll send you a link to a feedback form. It will take only 2 minutes to fill in. Don’t worry we won’t send you spam or share your email address with anyone.