Clinical data derived from the clinical investigation, post-market activities, and literature must be evaluated.
A well-defined appraisal plan is important as per MEDDEV 2.7.1 Rev.4
Clinical data derived from the clinical investigation, post-market activities, and literature must be evaluated.
A well-defined appraisal plan is important as per MEDDEV 2.7.1 Rev.4
Examples of aspects that can be taken into consideration for evaluating the methodological quality and the scientific validity
a. Pivotal data
b. Other data
When determining the relevance of each data set, a variety of factors should be considered. The table below illustrates some of the factors that could be considered when determining whether or not data is relevant to the clinical evaluation.
Clinical data, when generated through a well-designed and monitored randomized controlled clinical investigation conducted with the device under evaluation in its intended purpose, with patients and users who are representative of the target population, should typically receive the highest weighting.
Note: It is recognized that randomized clinical trials are not always feasible or appropriate and that alternative study designs can provide relevant clinical data with adequate weighting.
The reasons for rejecting evidence should be documented by the evaluators.
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