Clinical evaluation reports for MDR approval
The new European Medical Device Regulation went into effect in May 2021. According to the MEDEV 2.7/1 Rev. 4 guidelines, medical devices must be clinically evaluated: data on their safety and performance must be collected, evaluated and monitored. To this end, clinical data on the device must be collected, the available scientific literature must be evaluated, and clinical experience must be compiled in order to establish clinical evidence.
Products must be evaluated in the following terms:
- define the intended use
- provide clinical data on safety and performance
- identify gaps in the clinical evidence
- analyze, record and evaluate clinical performance
- determine the risk/benefit ratio
- monitor the product’s clinical impact after launch.
MEDCONTACT® offers the following services for MDR approval preparation:
- preparation of a product concept for the clinical utilization of the medical device (intended purpose, benefits, evidence, risks, risk-benefit ratio)
- compilation of clinical data: literature research, clinical studies, empirical data, etc.
- evaluation of identified data and analysis of relevant data to determine clinical safety and performance
- documentation and preparation of the clinical evaluation report