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The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO

#1
Hi guys, I have a question about the term used in MDR
Every time MDR mentions the term “Risk-benefit ratio" ?? It really means a "Ratio (a NUMBER)" ? such as "BMI" body weight index ???

For example, in MDR Annex I GSPR 2,
Reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the "Risk-Benefit Ratio"

and also found in GSPR 3(d), evaluate the impact of information from the production phase and, in particular, from the PMS system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, "Risk-Benefit Ratio" and risk acceptability;

The word "Ratio" could cause confusion...
My client have heard from their auditor and the auditor suggest them to use the "SEMI-QUANTIFY" method to treat benefits (just like we do for each risk into the different degree of harms) and then come up a ratio based two levels (e.g. risk level/benefit level).

It that reasonable? How can we make sure a "Risk-Benefit Ratio" by 0.5 or >1 is acceptable or not? (1 still can mean nothing)

In our opinion, an objective literature review of clinical data or survey from clinical experience ( like the methods used by FDA on the benefit-risk determination guidance for 510k or PMA) can provide better objective evidence than a "ratio”

Anyone provide suggestion is always welcomes
 
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planB

Super Moderator
#2
The MDR also uses terms such as "benefit-risk analysis", "benefit-risk profile" or "benefit-risk determination" in a similar context as "benefit-risk ratio". In my opinion, the "ratio" is acceptable when the benefit of the device is evaluated to outweigh the risks. There is no restriction that this evaluation/analysis cannot be performed in a descriptive, qualitative way.
 

yodon

Staff member
Super Moderator
#3
Agree with @planB - and, in fact, if you look at the guidance (24971:2020), they suggest framing benefits in terms of aspects like magnitude and probability the benefits will be realized. And when doing the comparison of benefits / risks, they talk to things like uncertainty and comparisons to similar devices. So it's expected, I believe, to be more of a (perpetual) "court case" where you establish the "evidence" for the benefits, compare with the "evidence" of the risks, and can hopefully come to a logical conclusion that the benefits outweigh the risks.

There's also a good discussion of approaches in section A.7.2) in MEDDEV 2.7/1 rev 4.
 
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