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EU Authorized Representative

Manufacturers of medical devices regulated by the Medical Device Directives/Regulations who are located outside the European Economic Area (EEA) must designate an Authorized Representative (AR) to be contactable by the national competent authorities and, under the new Regulations, carry out certain regulatory activities in respect of medical devices and in vitro diagnostic devices placed on the EEA market. 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 AR in Europe, and for the ARs themselves. In November 2022, the Commission published an updated version of the guidance to provide similar information for authorised representation under the MDR/IVDR, MDCG 2022-16. Donawa Lifescience has standard AR agreements which reflect the recommendations of these guidelines.

Medical device companies seeking AR services should designate only those companies that are qualified to offer such services and that can represent the company’s regulatory interests in an appropriate manner. The new Regulations also stipulate that ARs must have a ‘person responsible for regulatory compliance’ (PRRC), with specific educational and work experience requirements. Donawa Lifescience meets these new requirements and is able to provide expert regulatory advice to its AR clients on an as-needed basis.

Donawa Lifescience is also a founding member of the European Association of Authorised Representatives, an alliance of European Authorised Representatives who have joined forces to promote professional conduct and competence. EAAR members possess a shared vision of enhancing the quality of European Authorised Representation and aim to provide an understanding of European Authorised Representatives’ responsibilities to other stakeholders

Depending upon client company needs, Donawa Lifescience offers the following services:

  • assisting companies in understanding and complying with European medical device requirements, including Eudamed entry
  • identifying national language requirements
  • identifying national medical device registration requirements and completing the registration process
  • as an Authorised Representative, serving as the official contact with European authorities
  • receiving and transmitting information on adverse events and field safety corrective actions
  • if a medical device is intended for clinical investigations, notifying applicable national competent authorities
  • maintaining access to technical documentation within the EU

For further information and assistance, please contact us to see how we may be able to assist you.