According to the European directives a European Authorized Representative has to be designated by a manufacturer of medical devices that is not located within the European Community. The specific tasks of the European Authorized 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.
A European Authorized Representative (EC Representative, EC Rep) acts as the legal entity of manufacturers outside of the European Community and fulfills the manufacturer’s obligations according to the relevant European directives.
On behalf of the manufacturer the European Authorized Representative may deal with the European regulatory authorities regarding Declarations of Conformity, European labeling and language requirements, incident reporting, notification performance for clinical investigations, Free Sales Certificates or Certificates of Marketability as well as Certificates of product registration.
Winnova is your competent regulatory partner for the successful marketing of your medical devices in Europe.
Contact our Experts
European Authorized Representative Team Senior Consultant +44 (0) 1702 306 976
European Authorized Representative Team