Laws governing medical devices in the EU and their effect on free and open source software

States of the European Union recently implemented Directive 2007/47/EEC of September 5th 2007 concerning Medical Devices. This Directive amended Directive 93/42/EEC from June 14th 1993. Given that this Directive should now have become part of the national legislation of each EU Member State, it is a good time to take a look at how the provisions of the Directive could apply to open source software.