1. Clinical Evaluation
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 by technical and preclinical evaluation but also by clinical evaluation on the basis of sufficient and relevant clinical data.
One of the main challenges for clinical evaluators is to adequately reflect the 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 an active systematic life cycle process under the manufacturer's mandatory QMS.
From a regulatory 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 must generate, 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 the clinical evidence in conjunction with the clinical evaluation report (CER), following a proper process of clinical evaluation.
From an organizational perspective: The improvement of the clinical evaluation (CEV) of MDs has been one of the main target areas of the new medical device regulation (MDR). MDR is explicitly placing clinical evaluation as an active systematic life cycle process under the manufacturer's mandatory QMS. Clinical evaluation is now more closely integrated into the systemic context of the new regulation, especially with regard to its connections to QMS, PMS, risk management, manufacturers 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 a technological perspective it is expected that the device description within the clinical evaluation report 4 correctly identifies the current configuration of the medical device, including (but not limited to) the name, model, sizes, variants, components of the device (including software, accessories or intended product combinations). Clinical evaluators have to critic