10 July: European Parliament's medtech vote
This article was originally published in SRA
Executive Summary
The legislative committee at the European Parliament that is responsible for scrutinizing European Commission proposals for new medical device and in vitro diagnostic regulations has less than four months to propose and vote on amendments to the texts. ENVI, parliament’s environment, public health and food safety committee, is due to vote on the texts on 10 July.
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.