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Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch

The new Medical Device Regulation EU MDR 2017/745 and IVDR 2017/746 is providing some new vocabulary like “Economic Operators” and we will focus on one of them on this episode which is the Distributor.

The distributor has a particular responsibility within the new regulation. And this also means that some Distributors should update their Quality System or update some agreements they have with manufacturers.

Nicolaj Nitzsch is a Sales Manager at Scan-Med Norway and he is providing some support to understand what distributors should do to upgrade their system.

In this discussion…

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