Clinical Evaluation of Medical Devices: So much more than “just” a report
The MEDDEV was an expansion from a prior guidance and provided specific expectations for the clinical evaluation process for medical devices. Clinical evaluation is defined as “a methodologically sound ongoing procedure to collect, appraise, and evaluate if there is sufficient clinical evidence to confirm compliance with the relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use”. Prior to Revision 4 of the MEDDEV, clinical evaluation was generally considered a report completed as a part of the technical file, often by the regulatory department. This report was updated when changes were made to the device. This all changed in 2016 with the MEDDEV release. A quick PubMed search and a simple report were no longer adequate for clinical evaluation reports (CERs). The clinical evaluation is now a process made up of 5 stages that need to demonstrate the safety and performance of the device.
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