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The European Commission has issued an interpretative document (dated 2009-06-05) of Directive 2007/47/EC which amends Directive 90/385/EEC on active implantable medical devices and Directive 93/42/EEC on medical devices.
The changes concern, among others, the essential requirements which medical devices must satisfy in order to belawfully placed on the market, the corresponding conformity assessment procedures and the classification of devices. The Interpretation is available in our library. Or may be downloaded directly here.
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