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Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device
Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.
Guidance for healthcare professionals covers the use, management and safety of in vitro diagnostic (IVD) devices, including blood glucose meters.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
Guidance on the procurement of in vitro diagnostic (IVD) medical devices, their safety, quality and performance.
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD devices.
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