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EUROPEAN AUTHORIZED REPRESENTATIVE (AR)
 
 
REGULATORY REQUIREMENTS
 
 
Manufacturers of medical devices regulated by the MDR 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746/EU who are located outside the European Economic Area (EEA) and with no subsidiaries in the EEA must designate an authorized representative to carry out specific regulatory activities.
 
 
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 GEMARMED?
 
 
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.
 
 
GEMARMED AR SERVICES
 
 
Depending upon client company needs, Gemarmed offers the following services: