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Information and guidance on a range of medical devices for users and patients.
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.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Guidance on sources of electromagnetic interference and mitigating the risks.
Order a certificate of free sale to export medical devices outside the UK.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
Millions invested in eight innovative companies behind lifesaving new medical technology which could destroy liver cancer tumours, detect Alzheimer’s and quickly spot those at risk of stroke
Information for manufacturers, healthcare organisations and professionals, researchers, and patients & public on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD).
Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable.
List of medical facilities in Colombia
List of English-speaking practitioners and medical facilities in Dominican Republic.
Guidance for safe use in medical, surgical, dental and aesthetic practices
List of medical facilities and practitioners for British nationals in Central African Republic (CAR).
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.
Information about the EU Regulations and their implementation in Northern Ireland
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