UK Update: The New Model Clinical Investigation Agreement and the ABHI Code of Business Practice
This article was originally published in RAJ Devices
Executive Summary
Two recent developments in the UK – the implementation in the National Health Service of a model Clinical Investigation Agreement (mCIA)1,2 and a new code of business practice by the Association of British Healthcare Industries3 – represent significant changes to the legal and regulatory landscape for medical devices. The experience of the pharmaceutical industry under the model Clinical Trial Agreement (mCTA)4 and with the code of practice of the ABHI’s pharmaceutical counterpart, the ABPI, provides useful guidance on how to comply with, and utilise, these new additions to the medical devices framework.