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Volume: 5 Issue: 2
(February 2018)

new approach classification software medical device 7 december 2017 court justice european union (‘cjeu rendered judgment snitem france (case

Europe France EU

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A new approach to classification of software as a medical device?

On 7 December 2017, the Court of Justice of the European Union (‘CJEU’) rendered its judgment in Snitem et al. v. France (Case C-329/16), which essentially addressed the question of when software qualifies as a medical device within the meaning of the Medical Devices Directive (Council Directive 93/42/EEC of 14 June 1993). Christian Lindenthal and Dr Daniel Misch of Bird & Bird LLP dissect the rationale to the CJEU’s judgment and the practical implications.

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