Call for randomised clinical trials in EU for medtech is misplaced, says Eucomed head
This article was originally published in SRA
Executive Summary
A controversial report from the Belgian Health Care Knowledge Centre criticising the EU for failing when it comes to the pre-market demonstration of efficacy and safety of innovative, higher risk medical devices contains some significant misconceptions in the view of EU medtech industry association, Eucomed. Chief executive John Wilkinson explained to Amanda Maxwell his views on the premises adopted by the report's authors.