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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.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics.
Guidance on the procurement of in vitro diagnostic (IVD) medical devices, their safety, quality and performance.
Information about the EU Regulations and their implementation in Northern Ireland
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.
Notices of publication and a consolidated list for designated standards for in vitro diagnostic medical devices.
The workshop was held in Pune on Friday, 13 February 2015.
MHRA sets out new plans to protect patient safety and enable access without delay for UK patients to innovative medical technologies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
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
£500k is available to fund the development of novel PoC diagnostics devices.
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