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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 MHRA for the markets in Great Britain and Northern Ireland.
How to conform with the legal requirements for placing medical devices on the market.
Guidance for local authorities, trusts, schools, colleges and FE institutions about who owns DfE loaned devices, asset management and loan agreements.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Guidance for manufacturers of cardiac implantable electronic devices and their leads. It outlines specific scenarios that should be considered when determining if an incident is reportable.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
How to write clear and effective field safety notices (FSNs) for medical devices.
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