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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 on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Guidance on the procurement of in vitro diagnostic (IVD) medical devices, their safety, quality and performance.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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