The new Medical Device Regulation (MDR) of the EU classifies software used to take decisions with diagnosis or therapeutic purposes as class IIa. However, I cannot find a definition of "therapeutic purpose" in the MDR. In Article 2, MDR describes "medical purpose".
In New Zealand, the legal definition of therapeutic purpose is as follows (http://www.medsafe.govt.nz/regulatory/DevicesNew/1Definition.asp):
Therapeutic purpose - means any of the following purposes, or a purpose in connection with any of the following purposes:
Please let me know if you are aware of any legally accepted definition of "therapeutic purpose" in the EU.