For all classes of medical devices, manufacturers must now provide, as per Annex II, the information in the technical documentation to explain the design stages and procedures that applied to their device (this was significantly changed from MDD that required that design file will be included only in Class III). the main difference between classes is the dept required when dealing with the clinical evaluation report & with the PMS activities (a PMS plan that complies with the obligations of the manufacturers as referred to in Article 84 of the MDR, a Periodic Safety Update Report (PSUR) for devices greater than class I (Article 86 of MDR), or a PMS report for devices of class I (Article 85 of the MDR).