The three medical devices Directives, the Directive for Active Implantable Medical Devices (AIMD), the Directive for Medical Devices (MDD) and the In Vitro Diagnostic Medical Devices Directive (IVDD), ...

Linda Horton says changes won't affect U.S. companies much. Although changes to the European Union's Medical Devices Directives probably won't involve a major overhaul of the regulations or the system ...

The 2007 directive expands the existing definition of a medical device to cover "any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, ...

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/3bf989/european_union_eu) has announced the addition of GlobalData's new ...

LAUSANNE, Switzerland--(BUSINESS WIRE)--Neo Medical SA (Neo), a Swiss technology company specializing in spine surgery, today announced the approval of its entire product portfolio under the European ...

The CE Marking approval indicates that a medical device meets the requirements of the European Medical Devices Directive. Until now, Materialise’s personalized devices made use of the custom-made ...

In this free webinar, gain insight into how product safety compliance applies to connected medical devices and the testing pathways that support market access. Attendees will learn about the essential ...