Clinical evaluation without clinical data
WAIVER OF CLINICAL DATA
An omission of the clinical evaluation is not planned. A waiver of clinical data in the context of a clinical evaluation is conceivable for absolutely non-critical products and requires a clinical-scientific justification on the basis of preclinical data. The exception shall be justified by demonstrating compliance with the essential requirements by means of technical performance assessment, product testing and preclinical assessment alone and shall take into account the specificities of the body-product interaction, the intended clinical performance and the manufacturer's information.
If applicable, the Clinical Assessment Body, Prof. Zenner and Partner, may assist the Company in providing a reason for waiving clinical data in a clinical evaluation.
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