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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.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Find out when it's possible to get zero-rated supplies on medical and research goods and services that have been funded by charities.
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.
Guidance for healthcare professionals on managing specific medicines and medical devices and using them safely.
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.
Order a certificate of free sale to export medical devices outside the UK.
Medicines and Healthcare products Regulatory Agency (MHRA) guidance on using medical devices safely.
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Information on when software applications are considered to be a medical device and how they are regulated.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Posters and leaflets about using medical devices safely for healthcare professionals.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
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