Clinical Evaluation means it is the assessment and analysis of clinical data of a medical device to verify its clinical safety and performance, including the device’s benefits, when used as intended by the manufacturers.
It is a continuous process that is initially conducted during the conformity assessment process leading to the marketing of the device.
Clinical Evaluation is mandatory for CE marking.
The process is then repeated periodically throughout the life of the device as new clinical safety and performance information such as post surveillance reports or adverse reports and obtained during its use.
Pre-market research and development are guided by clinical evaluation. Manufacturers carry out Clinical evaluation to:
- Define need regarding clinical safety and performance of the device
- If the device is already in the market, then evaluate the clinical data.
- Conduct the gap analysis, and define which data is needed to generate with the device under the evaluation.
– If a gap is present that others cannot address, clinical evaluation should be planned to define the study design.
Post-market- manufacturer monitors the market and systematically collects clinical data on its product (PMS, PMCF)
The manufacturer must formulate a new plan, this plan includes to
- confirm the safety and the performance of the devices
- identify and monitor the side effect
- identify and investigate risk
- monitor the benefit/risk ratio
Know more: Top 20 Medical Device Acronyms & Terminologies You Must Know