New UK rules for medical devices trials

The UK has brought in new rules it says will make it easier to get permissions to carry out clinical trials of medical devices, such as hip and knee replacements, pacemakers and stents.

The new model Clinical Investigation Agreement (mCIA), covering all medical technology trials in National Health Service hospitals that are funded by industry, is intended to reduce bureaucracy.

Previously it was necessary to get permission from each site have local legal agreements drawn up before industry-sponsored trials could begin. Now there is a standard contract that covers all sites.

The agreement is one of a range of initiatives that have already been introduced to improve the clinical research environment.

Sally Davies, Director General of Research and Development, Department of Health said supporting research for, and in collaboration with, medical device industries is at the heart of the NHS’s research bureaucracy-busting agenda. “This agreement is one of a number of wide-ranging process improvements for clinical trials being introduced by the National Institute for Health Research Clinical Research Network.”