The EU Medical Device Regulation (EU MDR) requires more than a few new SOPs. A profound overhaul of...
Major Impact Expected on Medical Device and Clinical Regulations
Nearly a month after the official British vote to leave the EU – also known as the Brexit – the decision still dominates the daily news. There has been a great deal of debate on the impact this will have on the British economy, but one area that could face particular difficulties is the pharmaceutical, medical device, and clinical research industries.
The exit raises the possibility that the British medical industry could develop its own standards, adding a layer of expense and complication to an already chaotic compliance world. Within the industry, there are varying levels of concern with how Brexit will affect acquiring and keeping talent, obtaining clinical trials, and the future of British regulations. With the official British exit from the EU some time off still, the immediate impact will be minimal; however, these will be key points to watch as the industry adjusts to the new British position in Europe. – S.W.
Clinical Trials Arena - Industry Viewpoints: The potential impact of Brexit on UK clinical research