Description

Under the MDR, clinical evaluation must include an appraisal of clinical data to determine whether the evidence is suitable for establishing a device's safety and performance. If the data are insufficient, CE marking can be delayed or put at risk. Methodological quality and scientific validity are central to that appraisal. Manufacturers need to understand how their clinical data will be evaluated, what makes evidence suitable for its intended purpose, and how those conclusions should be documented in the Clinical Evaluation Report (CER). MEDDEV 2.7/1 Rev 4 provides detailed guidance on clinical data appraisal. MDCG 2020-13 sets out how notified bodies should document their clinical evaluation assessments. The challenge for manufacturers is ensuring that their study data will meet MDR expectations and withstand notified body assessment. On November 6, Maria E. Donawa, M.D., joins Friday In Focus to explain how clinical data appraisal works under the MDR and what manufacturers should consider when designing studies to support CE marking.