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

Aug 17, 2010, 16:05 (0 Talkback[s])
(Other stories by Ciaran Farrell)


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"Council Directive 93/42/EEC came about as it was recognised that the content and scope of the laws, regulations and administrative provisions in force in the Member States with regard to the safety, health protection and performance characteristics of medical devices and certification of such devices are different. This difference posed an actual threat to the free movement of good and services with the Community. As such, the Directive sought to harmonise national provisions with regard to the use of medical devices.

"Software as a 'medical device'

"As well as recognising various medical equipment and apparatus as 'medical devices', the 1993 Directive also recognised the role of software as potentially having important bearing on the proper functioning of such medical equipment. Article 2(a) of the 1993 Directive stated that "'medical device' means any instrument, apparatus, appliance [...] including the software necessary for its proper application intended by the manufacturer to be used for human beings [...]".

"The amending Directive of 2007 sought to broaden the scope of application of the legislation with respect to software..."

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