Observation 1 – This is the third installment of my series on medical device clinical evaluation. I suggest reading the first part at (http://www.medicaldevice.expert/) to have a better understanding of the concepts so the understanding of this part is easier).
The Clinical Evaluation Report – CER is the document which contains the results of the – application of the clinical evaluation requirements and process by the manufacturer, for a medical device. The MDR and also current MEDDEV 2.7.1 Rev 4 – Clinical Evaluation contains general information on the contents of the CER (the MEDDEV also provides a suggestion for a general TOC, however, they are too general and high level. We’ve been using a modified TOB based on the activities mentioned in the first post of this series (http://www.medicaldevice.expert/europe/ european-commission/medical-device-regulation/how-to-perform-a-clinical-evaluation-of- medical-devices-part-1-overview-and-sample-of-activities/). The suggestion is below.