Poor standards writing is threat to "new approach" in EU
This article was originally published in Clinica
Executive Summary
The EU medical devices industry needs to improve the quality, speed and efficiency of its standards-writing processes or it will risk exposing itself to a more prescriptive pharmaceutical-style regulatory regime. That was the warning given by Richard Moore, scientific director of the European medical device industry association, Eucomed, when he addressed a Brussels meeting on October 29 on risk management.