European authorized representative 

European Authorized Representative services for medical devices and in vitro diagnostics The regulations of the EU medical device directive 93/42/EEC (MDD), in vitro diagnostic directive 98/79/EC (IVDD), and the active implantable medical device directive 90/385/EEC (AIMDD) require a manufacturer located outside the European Economic Area (EEA) to designate a European Authorized Representative as a liaison to the European competent authorities. MT Promedt Consulting provides qualified and professional authorized representative services as required by the MEDDEV 2.5/10. Our services will support your company to comply with the European regulations and will open you the gate to the medical device market. MT Promedt Consulting European authorized service include: legal interface / product notification to the German competent authorities / identification of requirements for and performance of national notifications / storage of technical product files / identification of language requirements / notification of clinical investigations and performance evaluations / interaction with EU competent authorities / authorized European address / free sales certificate services product safety related activities / implementation of a medical device vigilance system / medical device incident and field safety corrective action (e.g. recalls) reporting system / liaison between manufacturer, distributors and European authorities