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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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Expert
Kristina Zvonar Brkić
Jan 22, 2022
If I understand correctly, they are distributors. Obligations of distributors are described in Article 14.
- EU MDR Article 14 - General obligations of distributors https://advisera.com/13485academy/mdr/general-obligations-of-distributors/
Please, go through the article and if you will have some more questions, do not hesitate to contact us.
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