Top 5 Reasons Notified Bodies Challenge CERs Under EU MDR (And How to Avoid Them) When a Medical Device Manufacturer receives a list of non-conformities or a request for additional information from a Notified Body, the cause is rarely structural or formatting-related. Under the Eur... CER Clinical Evaluation Report Compliance Risk Management EU MDR EUDAMED MDR (Medical Device Regulation) MDR Compliance SOTA (State of the Art) 7 Oct 2026 0 100