This Infographic provides an overview of the clinical evaluation process as required by the MDR (EU) 2017/745 and the MEDDEV 2.7 / 1 rev. 4 and GHTF SG5 N2R8:2007.

It ensures that both Manufacturers and Notified Bodies will adopt a consistent approach when it comes to developing, updating and performing the evaluation of the Clinical Evaluation Report (CER).

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