Directive 2007/47/EC: What are its Implications for Existing Medical Devices?

The regulatory framework governing medical devices in the European Union (EU) and, more particularly, the three basic Medical Devices Directives, have been amended on a number of occasions since their adoption. The most recent technical revision to the Directive on Active Implantable Medical Devices and the general Medical Devices Directive was through Directive 2007/47/EC, which was adopted in September 2007. This Directive makes no change to the Directive on In Vitro Diagnostic Medical Devices.


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