According to the European directives a European Authorized Representative has to be designated by a manufacturer of medical devices, in-vitro diagnostics and cosmetic products that is not located within the European Community.
The Authorized Representative acts on behalf of the manufacturer in all dealings with the regulatory authorities in the European Community. The specific tasks of the EC Representative are described in the medical device directives MDD 93/42/EEC and AIMDD 90/385/EEC, the in-vitro diagnostic directive IVDD 98/79/EC and the cosmetic directive 76/768/EEC.

 

European Authorized Representation

Medical Devices / Active Implantable Medical Devices / In Vitro Diagnostic Medical Devices / Cosmetic Products

MedNet GmbH with its unique combination of regulatory experience and expertise in addition to our marketing skills, is your best choice to provide you with the Authorized Representation services that you need for your success in Europe.

  • MedNet as your Authorized Representative has many years of experience in the area of medical devices, in-vitro diagnostic devices and cosmetic products
  • MedNet as your Authorized Representative has performed product registrations  according to the MDD 93/42/EEC, IVDD 98/79/EC, AIMDD 90/385/EEC and cosmetic directive 76/768/EEC for more than 10 years
  • MedNet as your Authorized Representative is capable of providing all the information you need in each EU Member state.
    MedNet can also perform individual country registrations, if necessary (Italian registration, Portuguese registration, Spanish registration)
  • MedNet as your Authorized Representative provides a certified vigilance system (incident reporting) according to the relevant directives
  • MedNet as your Authorized Representative assists in all issues regarding the post marketing surveillance
Contactthe MedNet EC Representative Team

 

EC Representation Services - MedNet provides