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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.
How a manufacturer can apply for approval to supply a non-compliant medical device on humanitarian grounds.
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.
An overview of the future requirements for rapid COVID-19 diagnostic assays for antigen lateral flow devices.
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 to conform with the legal requirements for placing medical devices on the market.
Guidance for local authorities, trusts, schools, colleges and FE institutions about who owns DfE loaned devices, asset management and loan agreements.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Information and guidance on a range of medical devices for users and patients.
Advice for manufacturers of Class I medical devices for placing products on the UK market
How to get fast-track approval of medical devices during COVID-19.
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.
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
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