24In that regard, 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 software is a medical device in its own right 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 further states that software for general purposes, when used in a healthcare setting, is not a medical device. The EU legislature thus made unequivocally clear that, in order for software to fall within the scope of Directive 93/42, it is not sufficient that it be used in a medical context; it is also necessary that the intended purpose, defined by the manufacturer, is specifically medical (judgment of 22 November 2012, Brain Products, C‑219/11, EU:C:2012:742, paragraphs 16 and 17). Software which does not meet that condition may fall within the scope of that directive only if it is an accessory to a medical device within the meaning of Article 1(2)(b) thereof. That software should then be treated, for the purposes of that directive, in accordance with Article 1(1) thereof, as a medical device in its own right.
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