Building a Quality Clinical Evaluation Report

MEDDEV 2.7.1 Rev 4 dictates new requirements for generating clinical evaluation reports (CER) properly. In this white paper, we explain the Rev 4 requirements in simple and concise terms. Regulators have shifted their focus on the quality of clinical evaluations with deeper scrutiny on the equivalence or predicate devices, selection of literature for review, patient sample in the literature, qualification of the evaluators, etc. There are many reasons behind these changes including recent adverse events in the market, responsibility to provide safe and effective medical devices and result of the work of GHTF to have global harmonized standards. We provide a case study to as an example of developing a clinical evaluation report on a Class IIb Implant. We hope that this paper provides you with the tools affective and accurate CER’s for your products.