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Guidance for healthcare professionals covers the use, management and safety of in vitro diagnostic (IVD) devices, including blood glucose meters.
Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Guidance on the procurement of in vitro diagnostic (IVD) medical devices, their safety, quality and performance.
Notices of publication and a consolidated list for designated standards for in vitro diagnostic medical devices.
Information about the EU Regulations and their implementation in Northern Ireland
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Device-specific guidance for manufacturers on reporting adverse incidents under the vigilance system
The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
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.
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.
Apply online to export sheep and bovine serum of non-UK origin for in vitro diagnostic use to Japan
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
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