EU scrutiny procedure could affect 1 in 10 high-risk devices
This article was originally published in Clinica
Executive Summary
Under 10% of high-risk medical devices entering the EU are likely to be subject to the new scrutiny mechanism that the European Commission has proposed. That is the estimate given by Manfred Kohler of the health technology and cosmetics unit (DG Sanco, B2) at the commission that issued the proposals last week.