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The following guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How investigators and sponsors should manage clinical trials during COVID-19
How to use a clinical audit to evaluate your digital health product.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
You can use the PRE service to view recordings of pre-recorded evidence before trial.
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.
How to write clear and effective field safety notices (FSNs) for medical devices.
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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