Clinical Evaluation Report

“The results of the clinical evaluation and the clinical evidence on which it is based shall be documented in a clinical evaluation report which shall support the assessment of the conformity of the device. The clinical evidence together with non-clinical data generated from non-clinical testing methods and other relevant documentation shall allow the manufacturer to demonstrate conformity with the general safety and performance requirements and shall be part of the technical documentation for the device in question. Both favourable and unfavourable data considered in the clinical evaluation shall be included in the technical documentation.” (Annex XIV, Part A, No. 4, MDR)

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