Manufacturers urged to prepare for revised EU devices directive
This article was originally published in SRA
Executive Summary
Medical device manufacturers in the European Union should take immediate steps to comply with the revised Medical Devices Directive before the new provisions come into effect in March 2010, according to analysts at the US-based research and advisory firm Nerac. In a white paper published on 2 December, Nerac warns that if devices currently on the market fail to meet the new requirements by the 2010 deadline, manufacturers risk having to withdraw products until compliance is established1.