EU experts fear Council may rush decision on MDD (Medical Devices Directive) review
This article was originally published in Clinica
Executive Summary
A key debate of the medical device regulatory system takes place this week. The EU Health Council is to meet on November 15, when ministers will discuss the ongoing five-year review of the Medical Devices Directive (MDD). Some industry and regulatory experts fear that an over-pessimistic view of the performance of the MDD may be presented at the meeting. If this happens - and if discussion time is monopolised by concerns over bioterrorism -the Council may reach a conclusion that more fundamental changes are needed than are generally considered necessary, thereby overriding the consensus view that minor changes are all that are needed.