As the risk-benefit ratio receives much more attention in the MDR than in the MDD, the term "clinical benefit" has also gained importance. It is a key element in assessing whether risks are acceptable. 🔑
In the MDR, the benefit-risk ratio is given a much higher priority than was the case in the MDD.
The frequency with which the term benefit-risk occurs in the MDR alone allows this conclusion to be drawn (27 times "benefit-risk in the MDR vs. 5 times "benefit/risk" in the MDD).
At the same time, "clinical benefit" became a central element as a measure of risk acceptance.
The MDR stipulates that [...] any risks associated with their use must be justifiable in terms of benefit to the patient [...]. ((EU)2017-745, Annex I, chap. 1, para. 1)
What is “Clinical Benefit”?
By definition, “Clinical Benefit” means
[...] the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health. [MDR, Article 2 (53)]
However, the MDR does not give us a tool with which the clinical benefit can be evaluated.
How can you evaluate the "clinical benefit"?
In order to make the "clinical benefit" assessable and comparable, tangible criteria are needed.
Here, CEN ISO TR 24971:202 and an FDA guideline* offer a conclusive approach.
*(Guidance for Industry and Food and Drug Administration Staff: "Factors to consider when making benefit-risk determinations in medical device premarket approval and de novo classifications")
As criteria for assessing the "clinical benefit", the importance of the positive effects of the product on the patient or patient management and the probability of occurrence and duration of this positive effect can be used.
This approach has clear parallels with the criteria for assessing risks.
Conclusion: Clinical Benefit
It can be assumed that many medical device manufacturers have yet to evaluate the "clinical benefit" based on these criteria.
The importance of "clinical benefit" in establishing the traceability of risk acceptance remains significantly undervalued.
Author: Bernhard Lindner, MSc
If you would like to learn more about the topic or are looking for support in evaluating the clinical benefit, please do not hesitate to contact us. Our risk management experts will be happy to advise you!
Further helpful links & resources:
SIFo Medical YouTube Channel: Short, valuable videos on Quality Management
MedTech Free Resources: Get free access to checklists & templates
TMV Guide: Your practical guide to perform test method validation (incl. templates & videos)
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