Clinical Evaluation
A systematic and ongoing process of collecting, appraising, and analyzing clinical data to verify the safety, clinical performance, and clinical benefits of a medical device. Clinical evaluation is required under EU MDR and forms part of the device's Technical Documentation.
Clinical evaluation is the methodical assessment of clinical data pertaining to a medical device to verify its clinical safety, performance, and benefits when used as intended by the manufacturer. Under EU MDR, clinical evaluation must be conducted throughout the entire lifecycle of the device, from initial conformity assessment through post-market surveillance.
Clinical evaluation process
The process involves: identifying relevant clinical data (literature, clinical investigations, post-market data), appraising data quality and relevance, analyzing the data to draw conclusions about safety and performance, and documenting everything in a Clinical Evaluation Report (CER). The CER must demonstrate that the device achieves its intended clinical benefits, that undesirable side effects are acceptable when weighed against benefits, and that the benefit-risk profile is favorable compared to available alternatives.
Clinical evaluation in tenders
Hospital procurement teams, particularly for high-risk devices, may request the Summary of Safety and Clinical Performance (SSCP) or clinical evidence summaries during tender evaluation. Strong clinical evidence — especially real-world data and peer-reviewed publications — can differentiate a supplier in competitive evaluations where multiple products meet the technical specifications.