European Authorized Representatives of Medical Devices, EC REP, CE Mark & In Vitro Diagnostic An European Authorized Representative is required in the European Medical Device Directives Medical Device Directive 93/42/EEC, Active Implantable Medical Devices 90/385/EEC and In Vitro Diagnostic Medical Device Directive 98/79/EC. An European Authorized Representative is in contact with the European Commission and the National Competent Authorities. CMC as your European Representative will put your company with the European Regulatory Requirements. Our Services of Authorized Representative are: Registration in more than 100 countries Free Sales Certificate CE mark Consulting FDA, KSA, CFDA, ISO 13485 OEM-OBL Agreements Regulatory Affairs CMC Medical Devices & Drugs also provide consultation about Technical Files, Regulatory Affairs of Medica Devices, OBL Agreements, Medical Device Directives (MDD), In Vitro Diagnostic Medical Device Directive (IVDD) and Active Implantable Medical Device Directives (AIMDD). If your company does not have a physical location in the EU, we are an official EU Authorized Representative of hundreds of medical device manufacturers worldwide. CMC Medical Devices & Drugs as your European Authorized Representative We are one of the largest Authorized Representatives for medical devices and IVDs, representing hundreds of medical device companies worldwide. Our familiarity with the European regulatory environment and Competent Authorities allows us to promote the best interests of our clients. We are an ISO registered firm which includes European Authorized Representation in the scope of our registration. You will receive free updates on European regulations for medical devices.
