Girish Hirpara, regulatory consultant on Kolabtree, provides a clinical evaluation report sample for medical devices to use as a template for MDR compliance.
The clinical evaluation report (CER) is a mandatory document for medical devices that are to be placed in the EU market. The CER is submitted along with the technical file to meet EU MDR requirements. If compliant, the device is awarded a ‘CE Mark’ which certifies that the device can safely be marketed/sold in the EU.
The clinical evaluation report documents the results of the clinical evaluation done for a medical device. It includes information on the safety and effectiveness of a device, data from clinical trials, technical design description, literature searches and more. The CER is specific to one device and has to be continuously updated throughout the life-cycle of the document, and therefore needs constant maintenance.
To help medical device manufacturers understand the overall flow and content of the CER, here’s a FREE sample or CER template that you can download. This document is intended to serve only as reference/guidance for medical device manufacturers.
Girish Hirpara is a medical writer with 13 years of clinical research experience. His expertise spans all aspects of regulatory compliance including ICH-GCP, MEDDEV 2.7.1/Rev 4, EU MDR 2017/745, EU IVDR 2017/746, ISO- 14155, SOPs, and others. Contact Girish for a project here.
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