New Regulation on Medical Devices: the obligations of Economic Operators

ECONOMIC OPERATORS

The new European Regulation 2017/745 on Medical Devices has reviewed the roles and obligations of the different Economic Operators (EOs): manufacturer, authorised representative, importer and distributor.

As you know, we are fast approaching its implementation date of 26 May 2021. It is therefore essential to understand now the definitions, statutes and responsibilities of each EO. We will be able to provide the following clarifications:

What are the definitions of the EOs concerned by Regulation 2017/745?
Do you know your obligations and responsibilities as an EO?
What are the dates to remember, related to the supply and use of Medical Devices, established by the new Regulation?

AGENDA

Reminder on the new Medical Device Regulation 2017/745,
The definitions of the main Economic Operators, their status and obligations under the new Regulation
The key dates to remember, related to the supply and use of Medical Devices.

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Raïssa ABDEL-KADER
Business Developer

After 6 years of experience as a sales representative with a good knowledge of long sales cycles, and a double technical-commercial skill, Raïssa joins EcoMundo in Paris in 2020.