Conducting the clinical evaluation

The safety, performance and risks of a medical device are analyzed and evaluated on the basis of the instructions for use, product information, test results, own clinical data and data from scientific literature. The clinical benefit for the patient must be greater than the risks associated with the use of the product.

A relevant factor for the safety of the product is its biocompatibility, which is examined and evaluated in a biological evaluation. The biological evaluation is therefore a prerequisite and an important part of the clinical evaluation.

Risks identified through the evaluation of the clinical data are compared with the risk analysis and the instructions for use of the product. From a regulatory perspective it is important that these three documents are consistent. 

Any questions regarding the risk-benefit ratio of the product are addressed and can be answered, for example, by future PMCF measures.