Could Clearing The Blurred EU Regulatory Lines For Non-Medical Brain Stimulation Devices Open Pandora’s Box?
This article was originally published in Clinica
Executive Summary
Transcranial brain stimulation devices with non-medical claims of enhancing people’s mental acuity are coming under the scrutiny of EU regulators, ahead of the adoption of the new Medical Device Regulation.
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.