Medtech Hopes It Is At Top Of Standards Request Queue After Backlog
Executive Summary
Controversy over the viability of EU harmonized standards, including in the medtech area, resulted in a hiatus for approving standards requests. Will the system be ready in time for medtech?
You may also be interested in...
EU Industry Is Ready To Accelerate, But EU Machinery Is Taking Baby Steps
The medtech industry remains frustrated about the time EU is taking to develop infrastructure for new device and IVD regulations. Despite much news from a recent gathering of a pivotal European Commission coordination group, MedTech Europe's Oliver Bisazza talks of persistent concerns.
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.