EU representative

Christian Burkhart-Sallmann

CEO HCTT EU Rep. Salzburg 

  • University of Zurich, Master in Business Economics, University Vienna, Master in Theology

  • 20 years of experience in Management Consulting and Digital Data Management

      www.sallmann-medical.eu

HCTT_team_Christian_Burkhart_Sallmann.jp

What is the role of an authorized EU representative?

The international guideline for Medical Devices Regulation (MDR) requires every manufacturer of medical devices outside of the European Community (EU) to select a company inside the EU as an authorised representative.
 
The role and responsibilities of an authorised representative are:​
  • They register the company’s products with the national competent authorities before they are marketed.​​
  •  They act as the company’s primary contact for all national competent authorities.​
  • They keep a current copy of the company’s technical documentation, which is available for inspection by the European competent authorities.​
  •  It allows the authorised representative to put their name and address on the company’s product labelling, packaging and user manuals.​
  • They are always available to interact with the company and the national competent authorities.​
  •  They are responsible for reporting incidents to the relevant authorities in collaboration with the company and distribution partners.​
  • They protect the confidentiality of the company’s documentation. The authorized representative of the European Union (EC REP) can only show the technical documentation to the competent authorities for legal basis.​
  • They represent the company at the European Commission for advice on the recall of a medical device by one or more Member States.​
  • They maintain reports of the critical evaluation of all data collected during the clinical evaluations for review by the competent authorities.