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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.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
How to conform with the legal requirements for placing medical devices on the market.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Information on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Information about the EU Regulations and their implementation in Northern Ireland
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