EU Court decides: Software as MD

On 7 December 2017, the Court of Justice of the European Union rendered a judgment in the case of Syndicat national de l’industrie des technologies médicales (SNITEM) and Philips France. The facts and arguments of the parties were previously discussed on this blog.

The Court followed the opinion of the Advocate General and decided that:

” …software, of which at least one of the functions makes it possible to use patient-specific data for the purposes, inter alia, of detecting contraindications, drug interactions and excessive doses, is, in respect of that function, a medical device within the meaning of those provisions, even if that software does not act directly in or on the human body..”

It also stated that:

“the EU legislature intended to focus, in order to classify software as a medical device, on the purpose of its use and not the manner in which the effect it is capable of producing on or in the human body is likely to materialise.”

Finally, the Court recalled the Commission’s Guidelines and added that:

” …where software is composed of modules which satisfy the definition of the concept of ‘medical device’ and others not, only the former must bear the CE marking; the others are not subject to the provisions of the directive,…As a result, the manufacturer of such software is required to identify which of the modules constitute medical devices, so that the CE marking can be affixed to those modules only.”

Read more about software as a medical device in our Particular topics section.

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