ENVI vote postponed: why that’s a good thing
This article was originally published in Clinica
Executive Summary
It’s disappointing, but hardly surprising. A critical vote at ENVI, the European Parliament’s lead committee on the Commission’s proposed EU medical device and IVD texts, that will determine the future of medtech regulation will not go ahead on18 September as planned but will likely take place next week.
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.