European Commission’s MD Groups: Committee Ready To Help With Implementing Acts
This article was originally published in Clinica
Executive Summary
Speculation that the European Commission may already be planning the first meetings of the proposed new Medical Device Coordination Group (MDCG) – a key player in the implementation of the future medical device regulations – is premature. But the commission has been making other significant plans in the context of the proposed new Regulations and one existing commission committee is being given a makeover,
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.