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Economic operator definition

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Guest user Created:   Jan 21, 2022 Last commented:   Jan 22, 2022

Economic operator definition

Not really sure whether I address the correct people, possibly this question came up more often. I distribute medical devices. The opportunity arises to expand our market and to deliver devices to customers of another company. We distribute the medical devices, the other company does not interfere at all with the device handling, traceability and follow-up processes (MDR obligations). They only send an invoice. Does that make them an economic operator with MDR obligations? Am I correct that if they do NOT touch the device at all with their processes (except for billing) that they will have no MDR obligations as “economic operator”?
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jan 22, 2022

If I understand correctly, they are distributors. Obligations of distributors are described in Article 14.

Please, go through the article and if you will have some more questions, do not hesitate to contact us.
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Jan 21, 2022

Jan 22, 2022

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