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
Register to vote Register by 18 June to vote in the General Election on 4 July.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
What animal by-products (ABPs) are, how to set up a site that uses them safely, the paperwork you need, and how to dispose of them.
Industry review identifying opportunities for development of financial products to help people pay for care.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
How to account for VAT on goods and services provided by registered health professionals, including doctors, dentists, nurses and pharmacists.
How to use a cost benefit analysis 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 get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Information and guidance on a range of medical devices for users and patients.
Resources to help anyone developing or running a digital health product to conduct an evaluation.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
How to use a cost effectiveness analysis to evaluate your digital health product.
How a product complies with EU safety, health and environmental requirements, and how to place a CE marking on your product.
Things to consider when buying and using products.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
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).