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Guidance for healthcare professionals covers the use, management and safety of in vitro diagnostic (IVD) devices, including blood glucose meters.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
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.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
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
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the medicine piflufolastat (18F) (Pylclari) as a diagnostic tool for people with suspected or known prostate cancer.
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
How to conform with the legal requirements for placing medical devices on the 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
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the Rubidium (Rb82) Generator (RUBY-FILL) as a diagnostic tool for imaging of the heart, to evaluate blood flow and aid in the diagnosis or assessment of...
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Information about the EU Regulations and their implementation in Northern Ireland
The different types of tests and testing kits for COVID-19, and the specifications for manufacturers.
Licences and authorisations to import genetic material, research and diagnostic samples, trade samples and display items, and some live animals and animal products.
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