Authors: Argyro Tsapakidou, LL.M.

Title: Increased responsibilities of medical device manufacturers in the amended European regulatory framework

Abstract

In April 2017 the European Parliament replaced the existing medical device directives (MDD) by adopting two new EU Regulations (MDR) on the use and marketing of medical devices and in vitro diagnostics. Main goal of those legislative changes is to provide safer and more effective products for patients and users as well as to rebuild the trust within the European Union towards the medical device regulations, after the implants scandal (PIP) in France and Germany in 2010. The distinctive element of the new Regulation is the expansion of the -already broad- responsibilities of medical companies: the manufacturers have to perform a strong post-market surveillance in order to gain as much information possible regarding the uses as well as “off label” uses of their products. These increased responsibilities, which are partially exceeding the respective responsibilities of the pharma industry manufacturers (since medicines are undergoing a state authorization procedure), may lead to suffocating circumstances towards small or medium size companies. Against this background, this paper aims to analyse the new legal framework and highlight its problematic aspects regarding the increased liability of the medical device manufacturers.