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Information and guidance on a range of medical devices for users and patients.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Find out when it's possible to get zero-rated supplies on medical and research goods and services that have been funded by charities.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
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.
How to conform with the legal requirements for placing medical devices on the market.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Order a certificate of free sale to export medical devices outside the UK.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Guidance for healthcare professionals on managing specific medicines and medical devices and using them safely.
Advice for manufacturers of Class I medical devices for placing products on the UK market
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Advice on writing clear notices and maximising replies to your FSNs.
How to get fast-track approval of medical devices during COVID-19.
Medicines and Healthcare products Regulatory Agency (MHRA) guidance on using medical devices safely.
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