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Risk/Benefit vs. benefit-risk - Revising an SOP covering Risk Management with the MDR in mind

MiamiDM

Starting to get Involved
#1
When revising an SOP covering Risk Management with the MDR in mind, should written reference to 'risk benefit' be replaced by 'benefit-risk' as the latter is the terminology in the MDR.
 

craiglab

Involved In Discussions
#3
"Benefit-risk" should be used. Not only MDR but FDA and others. The 14971:2018 draft stated "The term benefit-risk analysis is aligned with terminology used in some regulations."
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
My suggestion is to use the "new"term. We included it in the new revision of ISO 14971 because both the US FDA and MDR uses them, as mentioned by Craiglab. One of the reasons is that it makes it more clear that the benefit is important (when we say risk-benefit it may give the idea that the risk is more important). Also, this was changed to make it more clear that the manufacturers have to go after the benefits (in the past, the generic idea of regulations was that, if you managed the risk, the benefit would be there. Current and newer regulations will require that the benefit is measured, such as the MDR, when balancing it with the risk).
 

Ronen E

Problem Solver
Staff member
Super Moderator
#5
Current and newer regulations will require that the benefit is measured, such as the MDR, when balancing it with the risk
That's a problematic concept IMO.
The regulations (and perhaps the standard) imply a quantitative approach to the handling of benefits and overall risk. The only quantifiable measure (that I know of) common for both benefits and overall risk is money.
How do you quantify death or a serious injury or a 5-years extension of life in good/poor quality, for example, in money?
 

Al Rosen

Staff member
Super Moderator
#6
That's a problematic concept IMO.
The regulations (and perhaps the standard) imply a quantitative approach to the handling of benefits and overall risk. The only quantifiable measure (that I know of) common for both benefits and overall risk is money.
How do you quantify death or a serious injury or a 5-years extension of life in good/poor quality, for example, in money?
The cost of settling the law suits.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#7
The cost of settling the law suits.
I should have seen it coming...
1. Benefits aren't settled in court.
2. Court outcomes are not an objective measure but a function of attorney skills, which are a function of pocket depth.

In reality, I've never encountered a manufacturer who completed a water-tight, compliant risk management endeavour, summed up in monetary terms. The ones I worked with saw this as either too complicated to pull off or morally inappropriate.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#8
That's a problematic concept IMO.
The regulations (and perhaps the standard) imply a quantitative approach to the handling of benefits and overall risk. The only quantifiable measure (that I know of) common for both benefits and overall risk is money.
How do you quantify death or a serious injury or a 5-years extension of life in good/poor quality, for example, in money?
There's no requirement in the regulation (that I know of) nor in the standard that you only make quantifiable benefit/risk determinations. Benefit/risk determinations have been made for decades now (that's exactly the way medical device regulators work, in general) without it being about money.
 
#10
Hi Guys. New here. Me and a colleague are trying to figure out (based on the change in terminology and addition of the word "ratio") whether the MDR is indicating that a quantifiable measure of benefit-risk is required, as in the MDD there is no mention of "ratios" as such.
 
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