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Volume: 4 Issue: 8
(August 2017)

ags opinion sheds light software classified medical device whether software falls category classified medical device somewhat tricky question particularly pertinent

France Europe EU UK

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AGs Opinion sheds light on when software should be classified as a medical device

Whether and when software falls into the category of being classified as a medical device is a somewhat tricky question, and a particularly pertinent one given the proliferation of healthcare apps on the market. A recent dispute in France has led to a referral to the Court of Justice of the European Union (CJEU) in a case that may help to clarify the software as medical device question. AG Sanchez-Bordona, providing an opinion in this case, concluded that a prescription support tool such as the one in this case falls within the category of a medical device. Lorna Brazell, Partner at Osborne Clarke, reviews the case, the AGs Opinion and the relevant law.

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