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.