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 comply with the regulatory requirements for manufacturing custom-made medical devices.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
How to apply for an exceptional use authorisation to place medical devices on the UK market.
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.
Guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks.
How manufacturers can apply for approval to supply a non-compliant medical device on humanitarian grounds.
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
Information for clinicians and patients.
Phase 2 of the Airlock will include seven additional technologies spanning AI-powered clinical note taking, advanced cancer diagnostics, eye disease detection tools, and obesity treatment support systems.
Information about how approved bodies help regulate medical devices and how to apply for approval.
How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply.
A flyer to circulate to customers alongside a field safety notice covering what it is and why it's important to take action.
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
Information about suspected side effects of e-cigarettes and how to report side effects.
A poster explaining the different symbols used on medical devices.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
The Medicines and Healthcare Products Regulatory agency provides advice for producers of E-cigarette/vape products
Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
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).