European Authorized Representative Service

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) requires that a manufacturer located outside the European Economic Area (EEA) have to designate a European Authorized Representative as a liaison to the European Competent Authorities.

We are providing qualified and professional Authorized Representative Services in all European countries. Our services will support your company to comply with the European regulations.

Our European Authorized Service includes:

• Legal Interface
  • Product Notification to European Competent Authorities
  • Identification of requirements for and performance of national notifications
  • Identification of language requirements
  • Class I self certification package
  • Notification of Clinical Investigations
  • Interaction with EU Competent Authorities
  • Holding of Technical Product Files
  • Authorized European Address
• Product Safety Related Activities
  • Implementation of a Medical Device Vigilance System
  • Medical Device Complaint and Incident Reporting System
  • Liaison between manufacturer, distributors, and EU authorities

Our services will guarantee you full compliance with all EU regulations during the pre- and post-marketing phase in Europe. By appointing us as your independent representative, you will keep the highest possible flexibility in your distribution network. Our services will facilitate the fast entrance of your products into the European market.

If you wish to get EU Representative Certification, please send us an enquiry