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Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
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.
Sets out deliverables and timelines to support the development of safe In Vitro Diagnostic (IVD) medical devices.
Guidance on the procurement of in vitro diagnostic (IVD) medical devices, their safety, quality and performance.
Guidance on registration of certain in vitro diagnostic devices reliant on expired or expiring CE certificates or declarations of conformity.
Notices of publication and a consolidated list for designated standards for in vitro diagnostic medical devices.
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