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Economic Operators EU MDR 2017/745 Guidance Document
Economic Operators is a term not identified in the Medical Devices Directive 93/42 EC. Since the release of the new MDR EU 2017/745 Economic Operators have more responsibility. The EU MDR 2017/745 named the manufacturer, the authorised representative, the importer and the distributor as Economic Operators. Each economic operator has individual obligations, although all the economic operators have to collaborate together in order to make the device available on the market. The manufacturer must ensure that the supply chain - economic operators are aligned to the EU MDR.
Manufacturers shall establish, document, implement, maintain, keep up to date and continually improve a quality management system (QMS) to ensure compliance with EU MDR in the most effective manner and in a manner that is proportionate to the risk class and the type of device.
This document illustrates the relationship between the economic operators and addresses the responsibilities of each one. Through infographics and examples, this document aims to give the best guidance to the reader in order to become familiar with the economic operators adopted by EU MDR 2017/745.
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Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in the Medical Device, Biotech, and Pharmaceutical industries. Adnan founded Simplimedica in 2011 and has since supported Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. He has worked with start-up companies and multinationals to develop new products since 1999. With regulations tightening, especially in Europe, Simplimedica enables and simplifies the compliance conundrum to ensure manufacturers reach their desired market and stay in the market.
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