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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
The specifications will establish standards for high-risk diagnostic tests while creating consistency with European regulations
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
Guidance on the procurement of in vitro diagnostic (IVD) medical devices, their safety, quality and performance.
Notices of publication and a consolidated list for designated standards for in vitro diagnostic medical devices.
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