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Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Information and guidance on a range of medical devices for users and patients.
The MSA is a unit of the Defence Logistics Organisation responsible for the provision of medical, dental and veterinary supplies to the Armed Forces.
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.
Information about the EU Regulations and their implementation in Northern Ireland
How to apply for repayment of import duty and VAT on protective equipment or medical supplies brought into the UK from non-EU countries from 30 January 2020 up to 31 December 2020.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
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.
Medicines and Healthcare products Regulatory Agency (MHRA) guidance on using medical devices safely.
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.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Information on the measures in the Health Service Medical Supplies (Costs) Bill.
UK guidance on re-manufacturing of Single-use 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.
Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices.
Advice for manufacturers of Class I medical devices for placing products on the UK market
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.
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