What is meant by therapeutic purposes in MDR?

12 December 2017 0 5K Report

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:

preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury; or

influencing, inhibiting, or modifying a physiological process; or

testing the susceptibility of persons to a disease or ailment; or

influencing, controlling, or preventing conception; or

testing for pregnancy; or

investigating, replacing, or modifying parts of the human anatomy

Please let me know if you are aware of any legally accepted definition of "therapeutic purpose" in the EU.

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