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.