Girish Hirpara, consultor de reglamentación en Kolabtree, ofrece un ejemplo de informe de evaluación clínica de productos sanitarios para utilizarlo como plantilla para el cumplimiento del MDR.
El informe de evaluación clínica (CER) es un documento obligatorio para los productos sanitarios que se van a comercializar en la UE. El RCE se presenta junto con el expediente técnico para cumplir los requisitos del MDR de la UE. Si es conforme, el producto recibe el "marcado CE", que certifica que el producto puede comercializarse o venderse con seguridad en la UE.
The clinical evaluation report sample documents the results of the clinical evaluation done for a dispositivo médico. It includes information on the safety and effectiveness of a device, data from ensayos clínicos, 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.
Para ayudar a los fabricantes de productos sanitarios a entender el flujo general y el contenido de la RCE, aquí tiene una muestra o plantilla de RCE GRATUITA que puede descargar. Este documento está destinado a servir únicamente como referencia/guía para los fabricantes de productos sanitarios.
Girish Hirpara is a redactor médico with 13 years of clinical research experience. His expertise spans all aspects of cumplimiento de la normativa including ICH-GCP, MEDDEV 2.7.1/Rev 4, EU MDR 2017/745, EU IVDR 2017/746, ISO- 14155, SOPs, and others. Contacte con Girish para un proyecto aquí.
Kolabtree helps you contact freelance CER writers and medical device consultants, on demand. Tap into a global expert network and hire experienced medical device specialists who’ve worked in top companies like Abbott, J&J, Medtronic, Thermo Fisher Scientific, and more. You can also work with researchers who can help you understand with clinical trials, literature search, redacción de textos médicosy mucho más.
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