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

Br Dent J. 2018 Dec 14;225(11):1033-1036. doi: 10.1038/sj.bdj.2018.1033.

Abstract

Seeking regulatory and ethical approval is a significant task that must be completed before conducting a clinical trial of a medical device. Currently in the UK, the Integrated Research Application System (IRAS) is a unified system for preparing regulatory, ethical and governance applications for the relevant bodies that must approve health and social research. This article outlines key aspects in planning a clinical trial of a medical device and how applications for approval can be prepared using IRAS.

MeSH terms

  • Clinical Trials as Topic*
  • Equipment and Supplies*
  • United Kingdom