Starting with the creation of a Clinical Evaluation Plan, strategies, objectives, the scope, and the structure of the clinical evaluation are defined. The extent of clinical evidence is specified based on the product’s characteristics and intended use.
After defining the search and selection criteria, data is continuously collected, whether from clinical studies, scientific literature, or results of clinical investigations, throughout the product lifecycle.
Analysis and assessment
The collected data is analyzed and assessed: Is the data source reliable? Does it provide information on the product’s benefits and safety?
Report preparation (CER)
The Clinical Evaluation Report summarizes the results of the assessments and allows for conclusions regarding the benefits and safety of the medical device.
Clinical evaluation is part of quality management and an essential component of risk management. Clinical evaluation justifies the assumptions made about the benefits and risk acceptability in the risk management file. Therefore, the assumptions regarding identified risks need to be confirmed with the results of the clinical evaluation.
The regulatory requirements mandate a clinical evaluation throughout the entire lifecycle, including post-market clinical follow-up. The evaluation report must be updated continuously and proactively.