MDR Software Rule 11 Formal Interpretation

ralf90

Starting to get Involved
#1
Dear all,

Who knows of formal (read: EU, NB, IMDRF or alike) interpretation of the MDR software rule 11?

Thanks!
 
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yodon

Staff member
Super Moderator
#2
Where do you feel interpretation is needed? Maybe which physiological parameters are considered "vital"? (Just trying to stimulate the dialog, looking for more specifics.)
 

Ronen E

Problem Solver
Staff member
Moderator
#3
To me the vaguest phrase in Rule 11 is "a serious deterioration of a person's state of health". What makes is "serious"? This might determine whether the SW is class IIa or IIb. I haven't seen this term discussed in relation to the MDR yet, but MEDDEV 2.12-1 rev 8 (s. 5.1.1 (c)) has the following guidance:
A serious deterioration in state of health can include (non exhaustive list):

a) life-threatening illness,
b) permanent impairment of a body function or permanent damage to a body structure,
c) a condition necessitating medical or surgical intervention to prevent a) or b).
Examples:
- clinically relevant increase in the duration of a surgical procedure,
- a condition that requires hospitalisation or significant prolongation of existing hospitalisation.
d) any indirect harm (see definition under section 4.11) as a consequence of an incorrect diagnostic or IVD test result or as a consequence of the use of an IVF/ART device when used within MANUFACTURER´s instructions for use (use errors reportable under section 5.1.5.1 must also be considered).
e) foetal distress, foetal death or any congenital abnormality or birth defects.
The above has multiple issues in relation to the MDR clause though.
 
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ralf90

Starting to get Involved
#5
Indeed, this is the document I also use. What I presume is that there will become more 'formal' documents available, or interpretations of groups with an important opinion. I understood that MDCG made a draft document regarding this topic, but I cant seem to find this. Maybe someone else?

In this stage I think we all favor formal documents which have issues above having no documents or interpretations available.
 

ralf90

Starting to get Involved
#7
Where do you feel interpretation is needed? Maybe which physiological parameters are considered "vital"? (Just trying to stimulate the dialog, looking for more specifics.)
I am unsure about words like: "serious". Also I can imagine a timeframe of the negative consequences referred to are of importance. There are lots of diagnostic visualisations that in principle can lead to death if you take a timeframe which is long enough. Is this maybe meant the same as the 3rd point of rule 10?
 
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