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Clinical Evaluation Reports

Clinical evaluation of a medical device aims to show that the device offers more benefits and poses less risk than state-of-the-art treatments or is at least comparable to state-of-the-art technologies. Clinical evidence may come from literature, clinical investigations, and post-market surveillance (PMS). Both favorable and unfavorable data are to be considered in the clinical evaluation of the device.

The guidelines for the preparation of clinical evaluation reports have changed dramatically over the cross of the past decade. Clinical evaluation has evolved into a specialized field. It has become apparent that clinical evaluation should now be an integral part of the medical device design process to ensure the presence of adequate clinical evidence, prevent nonconformities, and address queries from notified bodies (NB).

Professionals engaged in clinical evaluations must possess comprehensive knowledge of the relevant guidance and regulations and the necessary documentation, including clinical evaluation plans and reports, literature protocols, and reports, and the ability to conduct methodologically sound literature reviews. Understanding the concept of “state of the art” and how to demonstrate equivalence is crucial. Additionally, it is essential to be proficient in gathering sufficient clinical data and conducting post-market clinical follow-ups.

The evaluators of clinical evaluation documentation must have appropriate qualifications and knowledge – medical and regulatory knowledge, device use knowledge, and academic literature review experience. Specific requirements for the expertise and experience of CER authors and evaluators include a relevant higher education degree, five years of related professional experience, or ten years of professional experience if a degree is not considered a prerequisite. Deviations from these requirements should be documented and duly justified. All evaluators must provide a declaration of interest.

The Revision 4 update of MED DEV 2.7/1 in June 2016 expanded the definition of clinical evaluation to encompass an ongoing process of collecting, evaluating, and analyzing clinical data about a medical device. It also involved assessing whether sufficient clinical evidence exists to confirm compliance with the essential requirements for safety and performance, as outlined in the manufacturer’s Instructions for Use. Subsequently, in April 2017, the Regulation (EU) 2017/745 for medical devices (MDR) was published, containing sections specifically addressing clinical evaluation (Article 61 and Annex XIV). These sections emphasized the need for a systematic process to continuously generate, collect, analyze, and evaluate clinical data related to a device to ensure its safety and performance when used as intended by the manufacturer.

These developments have substantially increased the complexity of the tasks assigned to CER writers. Now, they must familiarize themselves with over 80 Medical Device Coordination Group (MDCG) guidance documents, International Medical Device Regulators Forum (IMDRF) guidance, MED DEV 2.7/1 Revision 4 guidance document, as well as the requirements outlined in the EU MDR.

This article explains the stages involved in clinical evaluation, the necessary documentation, the literature protocol and review process, the key components of the CER, and post-market surveillance (PMS). The MED DEV 2.7/1 Revision 4 identifies five stages of clinical evaluation, an increase from the four stages in the previous revision. Stage 0 involves scoping the clinical evaluation, while Stage 1 entails identifying the relevant clinical data. In Stage 2, the accumulated data is systematically appraised and analyzed in Stage 3. In Stage 4, the clinical evaluation findings are documented in a comprehensive report, which includes conclusions regarding the safety and performance of the device.

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