The clinical appraisal plan derived from the clinical investigation, post-market activities, and literature must be evaluated. 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.
Plan and record the appraisal data of favorable and unfavorable clinical data in terms of its suitability, scientific validity, and data contribution. A well-defined clinical appraisal plan is important as per MEDDEV 2.7.1 Rev. 4.