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.
Service providers or government departments installing networking technologies in government shared buildings, known as hub buildings.
Guidance for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Further documents relating to the Medicines and Medical Devices Bill 2020.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
Information on MHRA's enforcement duties and how to report a non-compliant medical device.
The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review
Notices of publication and a consolidated list for designated standards for medical devices.
Thousands of counterfeit or unbranded copies of LifeVac anti-choking devices are being sold across the UK. The public is reminded to check their product carefully against the images in MHRA guidance to identify whether it is a counterfeit.
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.
List of certifications granted by the Secretary of State for Transport for approved devices, CCTV and associated evidence-recording equipment.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 May 2024) launched AI Airlock, its new regulatory sandbox for AI as a Medical Device (AIaMD).
Notices of publication and a consolidated list for designated standards for in vitro diagnostic medical devices.
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the modified MAGEC X system can now be used in the UK.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
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).