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

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. Specifically, Annex IX of the directive places a special emphasis on a new definition of a device’s time of use. The implications of this shift for manufacturers were discussed during a recent meeting with French competent authority Afssaps.

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