COCIR High Level Contribution To the Proposal for Medical Device Regulation Revision of Directive 93/42/EEC on Medical Devices

COCIR, the voice of European manufacturers of medical diagnostic and imaging, electromedical and healthcare ICT industries, welcomes the revision of the EU Medical Devices Directive (MDD) and its replacement with a new Medical Devices Regulation (MDR). The new Regulation should build on the many merits of the existing regulatory approach while remaining robust, transparent and adaptable to scientific and technological progress. The primary objective of the revision process must be to achieve smart and efficient regulation delivering patient safety, high quality and rapid access to innovative medical technology.
Since the very beginning of the revision process in 2008, COCIR has continually shared detailed input on all aspects of the proposed Regulation of relevance to our sector. This document is a high level contribution to all stakeholders involved in the revision process, and outlines COCIR’s respective comments on key matters. It is an updated version of our March 2014 contribution, taking into account new concerns since the European Parliament adopted its position in October 2013.
Our key messages and recommendations based on current developments and latest discussions at Council level are outlined below. Where relevant, the document refers the reader to more detailed COCIR documents that elaborate on the points made.