The fact that a software is not acting by itself within or upon the human body does not mean it cannot be classified as a medical device, explained the Advocate General Manuel Campos Sanchéz-Bordona in his conclusions delivered on Wednesday 28 June (C-329/16).
The Philips France company markets medical prescription assistance software used in the anaesthetics and resuscitation domain. This helps use a patient’s own data to assist a doctor establish their prescription by detecting side...