Unfavorable EU scrutiny procedure for high-risk devices may be scrapped by Council of EU
This article was originally published in Clinica
Executive Summary
“Almost all” member states representatives at the Council of the European Union believe the contentious “scrutiny” procedure for high-risk and innovative devices as proposed by the European Commission would be impossible to apply. That is according to a progress report prepared by the Italian Presidency of the Council of the EU for the 1 December meeting of the Employment, Social Policy, Health and Consumers Council.