Clinical Evaluation Report for Medical Devices
Clinical evaluation report (CER) is a document containing information regarding clinical evaluation of a medical device. CER is intended to be reviewed by the Notified Body (NB). Clinical evaluation refers to an organized procedure (Figure 1) used to collate, compile, and analyze clinical data related to a medical device. The clinical data includes updated published information on a medical condition and the medical device which is obtained from various databases. It also includes pre-clinical and clinical data, quality control data, and risk management and post-market surveillance related inputs which are obtained from manufacturers, quality and safety scientists, respectively. The clinical information also includes the instructions to be followed while using the medical device. The CER is prepared as per the guidelines mentioned in MEDDEV 2.7/1 Rev. 4 (June 2016). It specifies the structure as well as content to be added in the CER.
Figure 1: Organized procedure followed for Clinical Evaluation of a Medical Device
(Reference: MEDDEV 2.7/1 Rev. 4, June 2016, Section 6.3)
MEDDEV 2.7/1 Rev. 4 (June 2016)
MEDDEV 2.7/1 Rev. 4 (June 2016) is the guideline followed to prepare the CER. It includes summary of CER, updated published information about medical condition for which the medical device is used, as well as complete information about device under evaluation (Figure 2).
Figure 2: Table of content for development of Clinical Evaluation Report
(Reference: MEDDEV 2.7/1 Rev. 4, June 2016, Section 6.3)
Role of Medical Writer in the Development of Clinical Evaluation Reports
Medical writer plays an essential role in development of CERs. According to the requirements of MEDDEV 2.7/1 Rev. 4 (June 2016), the medical writer performs various activities (Figure 3).
Figure 3: Role of a medical Writer in development of Clinical Evaluation Report
Turacoz Healthcare Solutions, a medical communication company, provides latest updates on medical devices. Turacoz is dedicated in providing scientific/medical writing support to the industry and academia. With expertise in several clinical trial related documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs) and Common Technical Documents (CTDs), Prescribing Information (PI), we aim to deliver the best quality and guideline compliant documents to the Pharma and different sectors of Healthcare Industry.
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