AG Opinion: software assisting health professionals to prescribe the correct treatment for patients

In the case of Syndicat national de l’industrie des technologies médicales (SNITEM) and Philips France the French national court asked the Court of Justice of the European Union (ECJ) whether a software such as „Intellispace Critical Care and Anesthesia (ICCA)“, i.e. a software assisting medical prescriptions to patients falls under the definition of a medical device under the Directive 93/42/CE.

On 28 June 2017 the Advocate General issued an opinion, contrary to the view of the French Government and noted that the disputed software falls under the definition of a medical device under the Directive 93/42/CE, in particular in light of its functions.

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