Economic Operators Gap Assessment

Economic Operators Guidance Document

Table of Contents 1.0 Introduction ......................................................................................................................... 3 2.0 Scope and Objective ............................................................................................................. 3 3.0 Economic Operators under EU MDR ..................................................................................... 4

Identification within the supply chain ........................................................................................................... 7

4.0 Economic Operators under EU MDD ..................................................................................... 7 5.0 Comparison of economic operators under EU MDD and EU MDR (where possible)............... 9

Manufacturer ............................................................................................................................................... 9 Authorised representative ........................................................................................................................... 9 Importer ....................................................................................................................................................... 9

Appendix A: Explanation of economic operators under the EU MDR 745/2017 ........................ 10

1.0 Introduction Economic Operators have recently adopted by the new regulation EU MDR 745/2017, as agreed with the European Parliament and Council in May 2017. The new EU MDR is valid from the 26th of May 2020 and till this date, the medical devices must meet the new requirements of EU MDR. The EU MDD is now expanded to EU MDR, although many parts have changed, renamed or added. The EU MDR state that economic operators are the manufacturer, the authorised representative, the importer and the distributor and each of them have different responsibilities which are listed in the Articles 10,11,13,14 respectively. On the other hand, in the EU MDD, the economic operators are suggested to be the manufacturer which is welldefined, the authorised representative, the distributor and the suppliers which are referred through the regulation.

2.0 Scope and Objective This report is aiming to give guidance to the manufacturers, how to respond to their responsibilities and provide the authorised representatives, importers and distributors with their responsibilities in order to meet the requirements of EU MDR. The aim of this report is to collect all the information from EU MDR 2017/745 about the economic operators and give a description of the new requirements. In addition, where it is applicable the EU MDR is compared with EU MDD.

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Economic Operators Gap Assessment

Published on May 14, 2019

Pharmi Med Ltd

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.