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 register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Information on telecare monitoring systems and personal alarms that can help you stay safe and independent at home.
How to conform with the legal requirements for placing medical devices on the market.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
How to write clear and effective field safety notices (FSNs) for medical devices.
Information about the MHRA's duties and how you can report a non-compliant medical device.
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
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).