The Authorized Representative plays a vital role as it acts as your one point contact with the national Competent Authorities (Ministry of Health) and Notified Bodies.
Under the new MDR (EU) 2017/745 and IVDR (EU) 2017/746, Authorized Representatives (EC Rep) have greater responsibilities and take on significantly more risk and liabilities and thus it becomes instrumental to choose the right European Authorized Representative to support solid business growth in Europe ensuring optimum safety and performance of the device.