EC Rep

According to the Medical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746) you are obliged to appoint a European Authorised Representative (EC REP) if you want to trade your Medical Device(s) on the European market. AR Experts (part of Certification Experts) can act as an EC REP on behalf of your organisation.