Applying for regulatory approval of a clinical trial of a medical device in the UK – A practical guide

Key Points Highlights that planning and conducting a clinical trial is a lengthy process that must adhere to stringent regulations to ensure a high standard of ethics and reliability. Explains that clinical trials are divided into multiple phases; regulatory approval must be obtained for each one. Highlights that seeking approval is usually done after writing the protocol, securing funding and sponsorship, and appointing roles and responsibilities for members of the research team. Highlights that in the UK, a unified application system is available to simplify the process of applying for regulatory approval.