The EU MDR 745/2017 named the manufacturer, the authorised representative, the importer and the distributor as Economic Operators. Each economic operator has individual obligations in regard to the device are responsible for, although all the economic operators have to collaborate together in order to make the device available on the market. This document is illustrating the relationship between the economic operators and addresses the responsibilities of each one. Through infographics and examples, this document aiming to give the best guidance to the reader in order to become familiar with the economic operators adopted by EU MDR 745/2017.
Our templates are developed with consultants who have over 20 years’ experience in the Medical Device industry and documentation that has been through successful audits.
Our consultants are available, should you need further assistance in completing the documentation.