MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its conformity assessment procedures. Through the CEAR, the MDCG aims to standardize the documentation of the NBs’ assessment of manufacturers’ clinical evaluation and related documents.
Post assessment conclusions of the clinical evidence presented by the manufacturer in the clinical evaluation report (CER) and the related clinical evaluation conducted, must be clearly articulated by Notified Bodies (NBs) through this document.
What are the objectives of clinical evidence?
The clinical evidence presented by the manufacturer should evaluate whether the data from claimed equivalent devices is suitable while taking into consideration factors such as new indications and innovations. It should also verify the adequacy of itself, the clinical evaluation, and the conclusions drawn by the manufacturer on conformity with the relevant general safety and performance requirements.
Conclusions on the claimed equivalence and on the relevance and adequacy of the data to demonstrate conformity must be documented by the NB. Through pre-clinical and clinical data and risk analysis, the NBs must assess the extent of specific claims if any feature has been claimed as innovative or if the device has new indications.
The NB should also evaluate if the benefit-risk determination, risk management, instructions for use, user training, and the manufacturers’ post-market surveillance plan are sufficient. The NBs must also review the need for and adequacy of the PMCF plan proposed, wherever applicable.
Last, but not least, the clinical evaluation and the benefit-risk determination should be considered, with a recommendation on the possible definition of specific milestones to enable the NBs to review updates to the clinical evidence from PMS and PMCF data.
Key Points of the Clinical Evaluation Assessment Report (CEAR)
The CEAR recommends the support of a final review and the final decision to be made by the notified body.
CEARs in this format also support specific additional requirements, such as the clinical evaluation consultation procedure and reviews by designating authorities.
While the completed CEAR itself may not necessarily be a completely comprehensive record of the non-compliances/deficiencies, NBs may use this document to record the non-compliances/deficiencies and queries raised during the assessment and the assessment of responses received. CEARs will document the outcomes and conclusions of the assessment.
NBs are also made accountable for their assessment, as designating authorities will have access to the complete “audit trail” of the NB. Designating authorities will in turn assess if the NB conducted the clinical evaluation assessment properly, after consideration of the procedures, assessment, and associated documentation and conclusions.
·While expert panels conducting a clinical evaluation consultation procedure will assess the CEAR, they may not have access to the complete conformity assessment, related procedures, and documentation for the device. Hence, the CEAR is designed to provide adequate information concerning the clinical evidence provided by the manufacturer. The CEAR shall contain essential information such as benefit-risk determinations, the consistency of that evidence with the intended purpose, including the indications for use and the PMCF.
For the report to be complete, all pertinent sections should be completed, with corresponding boxes ticked, arriving at relevant conclusions. All tick-boxes should be completed only after all the non-compliances have been closed out, to indicate a positive assessment. If one or more open, minor non-compliances remain at the end of the assessment, they should be detailed in the template, with suitable suggestions on follow-up actions to close them out adequately. The expected corresponding completion timelines to be followed by the manufacturer under the supervision of the notified body should also be specified in the CEAR.
The data sources assessed would include the clinical evaluation report, clinical investigation plan, clinical investigation report, ethics committee approval, Competent Authority approval, post-market surveillance data, and relevant publications.
Based on the results of the manufacturers’ risk management and consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer, an assessment of clinical performance is conducted.
Here a summary of the clinical data, which demonstrates the ability of the device to achieve its intended purpose as claimed by the manufacturer, is presented, and a description of the clinical benefits is provided.
A vital component of the CEAR is the assessment of the qualitative and quantitative aspects of clinical safety. By determining residual risks, undesirable side-effects and confirming continuing compliance with relevant safety and performance requirements, an adequate assessment is performed.
The source and rationale for Equivalence must be established. For instance, if equivalence has been shown based upon clinical investigation(s) or other studies reported in scientific literature, the assessment must indicate which devices are/are not equivalent, and confirm that data relating to devices that are not equivalent have been excluded from the analysis of clinical data for the purposes for demonstrating safety and performance.
The implementation of the EU MDR will bring in stricter, post-market surveillance requirements, laying more emphasis on risk management, post-market clinical evaluation, and ensuring conformity to new specifications through the device lifecycle.
Thus, a clear, comprehensive template for the documentation of the Clinical evaluation assessment will not only help ease the ever-increasing burden for NBs with audits, timelines, and assessment guidelines but will also help manufacturers identify and focus on the crucial elements that critically impact the Clinical Evaluation Assessment.
Therefore, Clinical evaluation should be treated as a critical component of the manufacturer’s quality management process. The PMS, PMCF, and Instructions for use should align with the clinical evaluation to determine whether the risks are acceptable when weighed against the expected benefits, thereby eliciting any corrective and preventive actions involving the device.
The key takeaway concerning clinical evaluation for manufacturers and NBs is a demonstration and validation, respectively, of intended clinical benefits to patients, with relevant and specified clinical outcome parameters, while adhering to general performance and safety requirements with minimal residual risks.