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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.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
How to show MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Information and guidance on a range of medical devices for users and patients.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
MHRA performance metrics for clinical trials and established medicines assessment.
How investigators and sponsors should manage clinical trials during COVID-19
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
How to conform with the legal requirements for placing medical devices on the market.
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
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