European Medical Device Agency: four years' reflection:
This article was originally published in Clinica
Executive Summary
The creation of a European Medical Device Agency is the subject that has absorbed one PhD student for four years. Now the thesis of Sharon Frank, A New Model for European Medical Device Regulation: A Comparative Legal Analysis in the EU and the US, has been published by Europa Law Publishing in the Netherlands. Ms Frank proposes that the European Medical Device Agency should have a central role in the regulation of medical devices throughout the EU. Many of the concepts are based on FDA policies, with the FDA having "served as a source of inspiration". The book suggest why a European Medical Device Agency would be needed, and what would be the legal implications, competencies and structure. For more information, see: www.europalawpublishing.com