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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.
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.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
How to get fast-track approval of medical devices during COVID-19.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
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.
Information on content filtering and mobile device management to ensure devices are safe to use by young people and families
List of Field Safety Notices from 22 to 26 April 2024.
Using retractable or foldable aerodynamic rear devices on heavy goods vehicles.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Guidance for local authorities, trusts, schools, colleges and FE institutions about who owns DfE loaned devices, asset management and loan agreements.
How to conform with the legal requirements for placing medical devices on the market.
Information about the EU Regulations and their implementation in Northern Ireland
It’s illegal to hold a phone or a sat nav while driving - you'll get penalty points, a fine and can be banned from driving.
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.
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