Medical Device & IVD Regulatory Consultants in Europe Transitioning to the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) has placed unprecedented pressure on manufacturers. With Notified Body capacity severely limited, a rejected Technical File or a flawed Clinical Evaluation Report (CER) can keep your product off the European … Continue reading Medical device MDR consultants