Manufacturers marketing medical devices in Europe, but located outside the European Economic Area (EEA), should designate an Authorized Representative to serve as a local contact for regulatory matters concerning conformity with the Medical Device Directive or the AIMD Directive.
Although these Directives discuss the various roles that authorized representatives can play and although it is advisable for companies to designate an authorized representative, it is important to recognize that these Directives do not mandate this action. In contrast, the In Vitro Diagnostic Medical Device Directive (98/79/EC) does require that manufacturers of in vitro diagnostic devices located outside the EEA designate a European authorized representative.
Manufacturers should designate only those Authorized Representatives that are qualified to represent the company's regulatory interests. CMD Consulting meets this requirement and provides the following authorized representative services:
Contacting Notified Bodies to carry out activities related to the CE marking process
Serving as the official contact with European competent authorities
Receiving and transmitting to the represented company information on adverse events concerning its products
Notifying European authorities of the Member States in which clinical investigations are to be conducted
Maintaining all required technical documentation and clinical evaluation reports.