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
How to ensure the products you make or import comply with the law and are safe for consumers to use.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
How to use usability testing to evaluate your digital health product.
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.
How to begin with evaluating a digital health product, including when to evaluate, budgeting and getting support.
Your purchasing strategy must show you’ve considered commercial and technology aspects, and contractual limitations.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Information for manufacturers.
Information on cleaning an oil spill including your options, how to get a product approved and how long it will take.
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
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).