A clinical evaluation 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.
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 pre-clinical or clinical investigations, scientific literature and/or clinical experiences with similar devices.
Clinical evaluation reports should be considered live documents and 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 as and when more clinical data becomes available. This emphasises the importance of building the Clinical Evaluation report on solid foundations in order to facilitate subsequent revisions and incorporate relevant data.
Originally, the Clinical Evaluation Report, formed a significant part of a Technical File or Design Dossier. Following proposals for EU Regulation (EU MDR), as well as MEDDEV 2.7/1 revision 4 (June 2016), the Clinical Evaluation Report should now be looked as a standalone document summarizing any kind of data/evidence on the device under evaluation, in alignment with the intended claims, residual risks, benefits and risks as summarized into the Technical file or design dossier. The Clinical Evaluation Report should also be verifying these data do support any information and materials (Instruction for Use, Marketing brochures…) where device’s claim is being made to ensure it is accurately evidenced by data The Clinical Evaluation Report should also be thoroughly prepared with regards to any therapeutic alternatives, surgical practices, similar devices, in order to establish a solid State Of The Art, pre-requisite to any device development to address a clinical need. 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, or identify any alternative way of gathering evidence supporting a claim or addressing a risk (further pre-clinical tests, deeper risk analysis, re-design, etc.
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. 4 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 revision. 4, discuss notable changes from MEDDEV 2.7/1 revision 3, while focusing on the global benefits of the Clinical Evaluation Report for your product’s path to market.
Keywords: Clinical Evaluation Reports, MEDDEV