Prosystem USA LLC

Clinical Evaluation MEDDEV 2.7/1 Rev. 4

The clinical evaluation is required for each medical device regardless of its classification. Thereby, the MEDDEV 2.7.1 guideline is a helpful orientation with regard to the methodological approach as well as the documentation of the content. The clinical evaluation is a continuous process and needs to be kept up-to-date over the entire product life cycle. The requirements of the MEDDEV 2.7/1 Revision 4 increased significantly. According to the amendments, the clinical evaluation should no longer focus only on the safety and performance of medical devices; it should also take the benefit and usability for patients, user and third parties into consideration. In addition, the assessment of alternative treatment options is of greater importance in the fourth Revision. Moreover, the evaluation criteria for the analysis of scientific literature were substantially expanded.