A clinical evaluation assessment report (CEAR) is a report used by the notified body to clearly document the conclusions of its assessment of the clinical evidence presented by the manufacturer in the clinical evaluation report (CER) and the related clinical evaluation that was conducted – a core requirement of the Medical Device Regulation (EU) 2017/745 (MDR).
The clinical evaluation must be a part of the manufacturer’s quality management. It should also be aligned with and reflected in other aspects of the technical documentation, such as:
• The interface of the clinical evaluation with the risk management process and its appraisal and analysis of the preclinical and clinical evaluation and their relevance for the demonstration of conformity with the relevant requirements in Annex I.1
• Post-market surveillance including any corrective and preventive actions involving the device.
• Post-market clinical follow-up plan and where appropriate the post-market clinical follow-up report.
• Instructions for use, which provide adequate information on intended purpose, proper use and warnings about risks to patients and healthcare practitioners…