Clinical evaluation is the analysis and evaluation of clinical data pertaining to a medical device, in order to verify the clinical safety and performance. Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical device. It is performed during the conformity assessment process that leads to the authorization to place the medical device on the market, and it is repeated periodically during the use of the medical device in order to gain new information about its clinical safety and its performance. The information acquired during the clinical evaluation are used in the analysis of the risk and may result in changes to the Instructions for Use. It a specific responsibility of the producer to perform a clinical evaluation suitable to provide information on the efficacy and safe use of the device.
The EC guideline MEDDEV 2.7.1 is the reference document setting the principles to be followed during the clinical evaluation. The requirements here identified for clinical evaluation apply to all classes of medical devices.
According to the guideline, the clinical evaluation is based on a comprehensive analysis of available pre – and post-market clinical data relevant to the intended use of the device in question, including clinical performance data and safety data. These data might come from many sources: literature data, databases of adverse events or safety alerts (such as those held by many authorities), results of pre-clinical and clinical investigations, biocompatibility tests, analysis of equivalent products available on the market and feedback from the final user (in case of devices already on the market). The data collected must demonstrate the compliance of the device with the Essential Requirements.
The clinical evaluation is usually divided into different steps: data collection, weighing of the data collected in order to identify those most significant and final analysis of selected data. The results of this process are documented in the clinical evaluation report. The report must contain all the collected and analysed information. The organization of the information must reflect all phases of clinical evaluation (data collection, their assessment and subsequent conclusions) and make clear followed by the producer the scientific rationale on which the conclusion are drawn.
The clinical evaluation report is the only way to prove to the notified bodies and to the competent authorities (for example during CE marking procedure, to fulfill with post-market surveillance or during surveillance procedures) the clinical evidence supporting the use of the device.
As said before, the clinical evaluation is an ongoing process and the clinical evaluation report must be regularly reviewed and updated. Notably, MEDDEV 2.7.1 does not specify the frequency of the review but it is responsibility of the producer to define and justify the frequency at which the clinical evaluation needs to be actively updated.
RPN can support its clients in all phases of the process, from the preparation of the document (including the bibliographic research) to the maintenance and the update of the clinical evaluation reports of medical devices.