Commission Expert Panel Appointments Give Green Light To High-Risk Device Certification
Executive Summary
The appointment of the European Commission expert panels opens the door to full conformity assessment for innovative high-risk devices. But the uneven distribution of experts will mean queues are expected for some type of work.
You may also be interested in...
EU Expert Panels On The Starting Line But Waiting For Commission Whistle
The European Commission and notified bodies are now talking about how the expert panel process will work for high-risk devices.
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.