A clinical evaluation report is the assessment and analysis of clinical data needed to verify the clinical safety and performance of your medical device. A clinical evaluation report (CER) outlines the scope and context of the clinical evaluation of your device and includes the actual clinical data, the appraisal and analysis stages of the evaluation, and conclusions about device safety and performance.
In 2007, an amendment to the Medical Device Directive (MDD) 93/42/EEC and Active Implantable Medical Device Directive (AIMD) 90/385/EEC was made that essentially required every manufacturer of a medical device in Europe, regardless of device classification, to have a clinical evaluation report for their device.
The collection of clinical data is a critical aspect in the conformity assessment process of medical devices, and serves to substantiate a manufacturer’s claim regarding the safety, performance, and benefit/risk ratio of a given device. Clinical data is generally understood as evidence on the safety and performance of a medical device based on actual usage of the device, and is typically derived from preclinical or clinical investigations, scientific literature, and/or clinical experiences with similar devices.
Clinical evaluation reports are part of your Technical File or Design Dossier and should be considered live documents. The clinical evaluation report should remain active throughout the lifetime of the device with regular reviews and updates in relation to the results of post-market surveillance activities and when more clinical data becomes available. This emphasizes the importance of building the report on solid foundations. Completion of a clinical evaluation report when first conducting the conformity assessment (CE Mark) process can help manufacturers understand whether a clinical investigation is necessary or required.
In the post-market phase, continued evaluation of the device is essential for identifying further risks that occur with use of the device, and, if necessary, may result in changes to the Instruction for Use and product labelling.
The European Commission Guidance MEDDEV 2.7.1 rev. 3 Clinical Evaluation: Guide for Manufacturers and Notified Bodies provides details on the process of conducting clinical evaluations and the requirements for creating a clinical evaluation report. The document also provides a list of references that can be useful.
In this webinar, the speaker will examine the requirements listed in MEDDEV 2.7.1 rev. 3 while focusing on the global benefits of the clinical evaluation report for an individual's product’s path to market.
Keywords: Clinical Evaluation Report, Medical Device Studies