Change and the Regulatory Framework for Medical Devices in the EU

Respondents to the European Commission’s proposed “recast” of the European medical devices legislation have agreed that certain areas of device regulation need strengthening. Many stakeholders, however, have criticised the consultation for being premature in view of the 21 December 2008 deadline for member states’ transposition of Directive 2007/47/EC amending the medical devices and the active implantable medical devices directives, which is due to come into force in March 2010^1,2.