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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.
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.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Information about the EU Regulations and their implementation in Northern Ireland
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance for healthcare professionals on managing specific medicines and medical devices and using them safely.
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 a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
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
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