If you search Elsmar for "risk benefit", "risk-benefit", "risk/benefit", "benefit-risk" etc. you'll find a lot of discussions we already had on this topic.
Hi Ronen E, thank you for the suggestion about keywords used to search for thread for this topic (benefit-risk).
I tried your suggestions and think this thread (according to my personal opinion) is the most close discussion about this topic.
"The term "Benefit Risk Ratio" in EU MDR, do I need to present benefit risk analysis as a RATIO" started by
Regulustrator
h ttps://elsmar.com/elsmarqualityforum/threads/the-term-benefit-risk-ratio-in-eu-mdr-do-i-need-to-present-benefit-risk-analysis-as-a-ratio.80432/
(If anyone is watching any thread about this topic and would like to share it will be a great thing.)
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As for the benefit estimation, I try to quickly go through guidance/standards, and find what they provide are principles and qualitative way about benefit estimation. The guidance/standards I review are:
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Meddev 2.7.1 rev 4 A7.2.
- ISO 14971
- ISO 24971
- US FDA Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications Appendix B Worksheet for Benefit-Risk Assessment (ps. the one I think most detail about benefit estimation)
So I think there isn't public guidance about qualitatively estimate benefit yet?
Please correct me if I am wrong.