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Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Information on road traffic devices, such as breath-testing, speed cameras and immobilisation devices.
Information and guidance on a range of medical devices for users and patients.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
How to get fast-track approval of medical devices during COVID-19.
Order a certificate of free sale to export medical devices outside the UK.
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.
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