Call for RCTs and tighter clinical requirements in EU is misplaced, says Eucomed head
This article was originally published in Clinica
Executive Summary
The controversial report from the Belgian Health Care Knowledge Centre criticising the EU for failing when it comes to the premarket 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
You may also be interested in...
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.
First Danish Notified Body Named Under EU's Medical Device Regulation
The EU now has a total of 45 notified bodies under the MDR.