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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).
Information about the EU Regulations and their implementation in Northern Ireland
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Checklists providing a practical guide to using medical devices.
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
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Links to EU guidance, as it stood immediately before end of transition period.
How to get fast-track approval of medical devices during COVID-19.
The MSA is a unit of the Defence Logistics Organisation responsible for the provision of medical, dental and veterinary supplies to the Armed Forces.
Guidance on sources of electromagnetic interference and mitigating the risks.
How the supply of medical devices from Great Britain into Northern Ireland works.
You can claim relief to pay no Customs Duty or VAT if you’re importing donated medical equipment from outside the UK and EU.
The MHRA welcomes the publication of Dame Margaret Whitehead’s Equity in Medical Devices: Independent Review
Advice on writing clear notices and maximising replies to your FSNs.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
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