“A digital healthcare application is defined [by regulations] as a medical device that demonstrates the following characteristics:
- It is a medical device falling into Risk Class I or IIa (either according to the Medical Devices Regulation – MDR – or under the Medical Devices Directive –MDD – transitional regulations)
- The primary function of a digital healthcare application must be based on digital technologies.
- The medical purpose of the application must be achieved primarily by means of its principal digital function.
- The digital application must support the detection, monitoring, treatment or alleviation of illness, or the detection, treatment or alleviation of injuries, or be designed to compensate for injuries or disabilities.
- The digital application must be used by the patient, or jointly by the patient and a service provider.”
