MDR Rationale Classification

The classification of a medical device is the responsibility of the Manufacturer. An incorrect process of identifying the medical device and its classification can lead to incorrect decisions about pre-clinical studies to be developed or approval procedures to be applied with waste of time and resources. In Cebis we help companies to apply the classification rules unequivocally and, after a study of the medical device, we elaborate the Justification of Classification based on the indications of Annex VIII of Regulation (EU) 2017/745 and the most recent official guidelines issued by the MDCG Group.