16Next, it must be stated that the wording of Article 1(2)(a) of Directive 93/42 was amended by Article 2 of Directive 2007/47, recital 6 of which states that a software in its own right is a medical device when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device. That recital adds that software for general purposes when used in a healthcare setting is not a medical device.
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