1. Clinical Evaluation
1.1. Introduction
Both in the old and new EU regulatory system for medical devices (MD), the manufacturer has to demonstrate safety and performance of MDs not only bytechnical and preclinical evaluation but also byclinical evaluation on the basis of sufficient and relevant clinical data.
One of the main challenges for clinical evaluators is to adequately reflectthe complex character of the clinical evaluation, ranging from regulatory, organizational, technological to clinical aspects. Subsequently, the expectations on the documentation of the clinical evaluation are manifold and in large parts related to the perspective of evaluators serving manufacturers or third parties (National Competent Authorities, Notified Bodies, Public…). This complexity is additionally increased since MDR is explicitly placing clinical evaluation as anactive systematic life cycle process under the manufacturer's mandatory QMS.
From aregulatory perspective: In order to assure that the expectations, claims and requirements concerning clinical safety and effectiveness are fulfilled in the intended target population(s) and indications, the manufacturer mustgenerate, identify, appraise, analyse, evaluate, document and update sufficient and methodologically valid clinical data over the life-cycle of the MD (including PMCF1) and demonstrate this as theclinical evidence in conjunction with theclinical evaluation report (CER), following a properprocess of clinical evaluation.
From anorganizational perspective: The improvement of the clinical evaluation (CEV) of MDs has beenone of the main target areas of the new medical device regulation (MDR). MDR is explicitly placing clinical evaluation as anactive systematic life cycle process under the manufacturer's mandatory QMS. Clinical evaluation is now moreclosely integrated into the systemic context of the new regulation, especially with regard to its connections to QMS, PMS, risk management, manufacturer’s obligations (Art. 10), demonstration of conformity with the general requirements for safety and performance (Annex I), technical documentation (Annexes II and III), tasks and competencies of notified bodies (Annex VII) and to conformity assessment (Annexes IX-XI2).
This also implies that the interconnections to other processes have to be established and be continuously evaluated. This integration into the quality management system requires that the responsible persons involved are adequately qualified3 - a respective rationale also needs to be provided if (parts of) the process is outsourced. These aspects can be seen as the organizational framework for the activities related to the clinical evaluation.
From atechnological perspective it is expected that the device description within the clinical evaluation report4 correctly identifies the current configuration of the medical device, including (but not limited to) the name, model, sizes, variants, components of the device (including soft