Europe In Brief

Guidance on revisions to Medical Device Directives: On June 5, the European Commission issued 1guidance on revisions made to the Medical Device Directives in 2007 that will take effect on March 21, 2010 via Directive 2007/47/EC (2"The Gray Sheet" June 1, 2009). The guidelines recommend that manufacturers of new types of devices, devices that have been reclassified under the revised classification rules and devices undergoing changes subject to prior assessment by a notified body complete a conformity assessment by a notified body before that date. Products already on the market prior to the 2010 deadline to which the revisions do not apply will only be subject to general market surveillance provisions. Manufacturers of all classes of devices on the market before the 2010 deadline must issue a Declaration of Conformity for that device stating compliance with Directives 90/385/EEC or 93/42/EEC, as amended by Directive 2007/47/EC. If the device's conformity evaluation requires a notified body, that notified body must check compliance with the new legislation