EU notified bodies shake-up needed…now! Medtech industry calls would alter system as we know it
This article was originally published in Clinica
Executive Summary
How do you achieve a trustworthy medical technology regulatory system if you say no to the “scrutiny” procedure being proposed by the European Commission? Amanda Maxwell interviewed Serge Bernasconi, head of Medtech Europe, the alliance of European medical technology industry associations, to dig deeper into alternative proposals being suggested by industry and the preliminary reactions of the European Parliament and Council to industry’s “outreach” efforts