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Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
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.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
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
Information about the EU Regulations and their implementation in 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.
How to conform with the legal requirements for placing medical devices on the market.
Information on when software applications are considered to be a medical device and how they are regulated.
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.
Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices.
Check the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
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.
Posters and leaflets about using medical devices safely for healthcare professionals.
You can claim relief to pay no Customs Duty or VAT if you’re importing donated medical equipment from outside the UK and EU.
Advice for manufacturers of Class I medical devices for placing products on the UK market
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