The interpretation of rule 11 is that all software that is a medical device will be covered by Rule 11 - "information which is used to take decision with diagnosis or therapeutic purposes" covers everything listed in the medical device definition.
The non-bold items listed are considered to be either diagnostic or therapeutic purposes.
The non-bold items listed are considered to be either diagnostic or therapeutic purposes.
Draft MDCG Software qualification & classification guidance for sign-off this week.
(I'm on the EC work group)
(I'm on the EC work group)
But commenting on your comments, from the medical science literature, the itens I listed not in bold are not the same as diagnostic or therapeutic purposes (for people not aware of that, I suggest reading something like the (Users' Guides to the Medical Literature: A Manual for Evidence-Based Clinical Practice, 3rd ed).
From the draft and final text of the MDR, my interpretation is that the regulations was created leaning towards Evidence-Based Medicine (which makes sense) and this can be seem, for example, on the systematic review framework the regulation (and the MDD and MDDDEV) defined for Clinical Evaluation.
The separation and granularity, on the definition of medical devices (eg. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease) also points to this, because they reflect much more what Evidence-Based Medicine uses for each.
Now, if you say the Software working group (hopefully there we physicians participating) is trying to change how the world treats these terms, and that the group is saying that all of them are under diagnostic or therapeutic purposes, even if the medical science literature clearly separates them, I would think the proposed document will same some problems being accepted (well, it's a guidance document anyway, so there is not a problem in itself, but I would really prefer that guidance documents are not technically wrong).
