I'm trying to budget for the upcoming assessments to the EU MDR. I understand that no devices will be grandfathered under the new MDR. However, does this mean all technical files have to be re-assessed under the new MDR? Reading article 52 clause 4, class IIb devices that are a suture, staple, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connnectors, would have a sample assessment of the technical documentation from each generic device group. I am assuming that generic device group equates to GMDN code as it was under the MDD. If it is some other type of class IIb implant, then all technical documentation has to be assessed. Do I have this correct?