Clinical Evaluation

Medical device manufacturers are required to have their products clinically evaluated or updated to meet the requirements of the MDR.

The clinical evaluation is critically reviewed against available product data and serves the following objective(s):

1. The manufacturer must demonstrate that theclinical benefit of the medical device(s) is sufficient. Depending on the risik class of the device, the literature route or the conduct of a clinical trial may be chosen for the clinical evaluation.
2. Manufacturers must ensure that their medical devices do not cause unexpected and unacceptable adverse reactions.
3. The appropriate purpose/ claims of the manufacturer must be proven.