EU member state opposition grows against medical device 'scrutiny' procedure
This article was originally published in SRA
Executive Summary
'Almost all' member states representatives at the Council of the European Union believe the contentious 'scrutiny' procedure for high-risk and innovative medical devices as proposed by the European Commission would be impossible to apply1. That is according to a progress report that the Italian Presidency of the Council of the EU has prepared on the proposed medical device and IVD regulations for the 1 December meeting of the Employment, Social Policy, Health and Consumers Council.
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.