The Medicines and Healthcare products Regulatory Authority (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health.
If your study is a clinical trial of a medicinal product, you’re required to obtain a clinical trial authorisation (CTA) from the MHRA before the research can start, via the integrated research application system (IRAS).
If your study is a clinical investigation or other study of a medical device, you may need to notify the MHRA and obtain a letter of no objection before you can carry out your study. Please see the MHRA website for information on how to notify the MHRA of your clinical investigation.