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A Quantitative Approach to Benefit-Risk Determination

Under the Medical Device Regulation (2017/745) (MDR), demonstrating clinical benefit and quantifying benefit-risk ratios are critical to compliance. A medical device must not be placed on the market if the benefit of the product does not outweigh the risk in a clearly quantified and documented benefit-risk analysis. Qualitative arguments are inherently subjective to some degree – an issue that can be addressed by a quantitative approach.
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