What Is Certification Evaluation Report (CER)?
The Details Of CER
This document is needed under the new MEDDEV 2.7.1 Rev. 3 guidelines. This document has the information and the outcome produced by the devices during the evaluation of the clinical safety and the performance of the medical device.
The Recent Glossary Definitions Of CER
Proposition Of Value
The value proposition contains a common understanding of the patient flow to recognize where the value is being lost and where the new value can be developed and how the company can manage in the best way to procure that value.
Health Economics and Outcomes Research (HEOR)
It is the most common label provided to the functioning within the pharmaceutical and life science companies having the responsibility for generating the evidence of the value of the new interventions for the reimbursement agencies.
Monitoring the Plan
This describes the monitoring processes, responsibilities, and requirements for the trial. It further includes a brief detail of the study, its objectives and the critical data and the study procedures. This plan describes the reference policies and the procedures to follow.
Etmf/TMF: Electronic Trial Master File/Trial Master File
The electronic or the paper filing system that must contain all study documents and the essential documents as mentioned in ICH E6.
This authority is responsible for the authorization of medicines and medical devices.
Project Management Plan
The reason for this document is to define the extent of activities, outlining the responsibilities defining the tasks and roles and providing guidance on a specific project.
Services Offered By CER Consultant
If you employ a CER Consultant the following services are offered to you for reducing the burden of your regulatory requirements.
The Clinical Evaluation Reports are required by all the manufacturers that produce medical devices in Europe. CER is needed to be submitted to the Notified Body (NB) as an additional document for your European CE Technical File. The Technical File is a very significant step to obtain the CE Marketing for your device that is required to sell or distribute all your medical devices in Europe. The expertise of the consultants efficiently functions to achieve this.