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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.
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.
Order a certificate of free sale to export medical devices outside the UK.
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 MSA is a unit of the Defence Logistics Organisation responsible for the provision of medical, dental and veterinary supplies to the Armed Forces.
Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices.
Information on when software applications are considered to be a medical device and how they are regulated.
Information about the EU Regulations and their implementation in Northern Ireland
Guidance for healthcare professionals on managing specific medicines and medical devices and using them safely.
UK guidance on re-manufacturing of Single-use medical devices.
Medicines and Healthcare products Regulatory Agency (MHRA) guidance on using medical devices safely.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
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.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Advice for manufacturers of Class I medical devices for placing products on the UK market
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