Obelis European Authorized Representative Center provides ISO certified services for the successful introduction of medical devices within the European territory, in accordance to the Medical Device Directive 93/42/EEC and its amendment 2007/47/EC, In-Vitro Diagnostics Directive 98/79/EC and Active Implantable Medical Devices Directive 90/385/EEC.
Those services include, but are not limited to, the following:
- European Authorized Representative services (EC Rep)
- Pre-market notification of Class I devices and notification of the preliminary clinical investigations
- Post market advisory services
- Pre-CE marking services
- Free sales certificate services
- Certificate of CE registration
- GMDN code research services
Our services are backed by over 25 years of experience with CE Marking consultation and European Authorized Representative services. We are located within walking distance of the European Commission and maintain close relations with the EU Administration.