REGULATORY REQUIREMENTS
 
Manufacturers of medical devices regulated by the Medical Device Directive (93/42/EEC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC) who are located outside the European Economic Area (EEA) and with no subsidiaries in the EEA must designate an authorized representative to carry out certain regulatory activities.
  
Directive 2007/47/EC revised the Active Implantable Medical Devices Directive and the Medical Devices Directive with effect from 21 March 2010, making it a requirement for non-European manufacturers to designate an Authorized Representative - previously it was voluntary. 
 
 
In January 2012, the European Commission published a guidance document for Authorised Representatives, MEDDEV 2.5/10, providing guidelines for both manufacturers seeking to designate an Authorised Representative in Europe, and for Authorised Representatives themselves.
 
 
WHY SELECT GEMAR
 
European Authorized Representative services are important because, in the event that a regulatory authority is unable to contact a company directly or expeditiously, this authority may provide information or documents to the Authorized Representative. This action is considered to be equivalent to providing the same information or documents to the company.
 
Therefore, medical device companies seeking Authorized Representative services should designate only those companies that are qualified to offer these services and that can represent the company's regulatory interests in an appropriate manner. Gemar meets this requirement. 
 
 
GEMAR AR SERVICES
 
Depending upon client company needs, GEMAR offers the following services:
  
  • assisting companies in understanding and complying with European medical devices requirements
  • identifying national language requirements
  • identifying national medical device registration requirements and completing the registration process
  • contacting Notified Bodies to carry out activities related to the CE marking process
  • serving as the official contact with European authorities if a Member State takes measures to withdraw a medical device from the market or prohibits or restricts its being put into service
  • receiving and transmitting information on adverse events related to a medical device
  • if a medical device is intended for clinical investigations, notifying European authorities of the Member States in which clinical investigations are to be carried out
  • maintaining technical documentation and clinical evaluation reports within the EU