When does stand-alone software qualify as a medical device in the European Union?: The CJEU decision in SNITEM and what it implies for the next generation of medical devices
This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable EU regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the softwar