Revising Directive’s Time-of-Use Clause May Cause Reclassification of Devices

Tuesday, March 9th, 2010

Medical device manufacturers are required to comply with Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC by 21 March 2010. Despite having made every effort to meet the essential requirements, companies may be surprised to learn that the classification of some of their devices may be challenged, writes René ...