Abstract

By its judgment of 7 December 2017, the European Court of Justice replied to a request for a preliminary ruling from France regarding the legal qualification of a drug prescription assistance software. The European Court judged that this kind of software, since it has a medical purpose, is a medical device. It must therefore bear the CE marking of conformity, when it is placed on the market, but cannot be the subject of any other procedure, such as an additional certification imposed by a national regulation.

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