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, you will see that a lot of things were already in place for distributors before the new Medical Device Regulation, but with the MDR and IVDR, this should now be properly documented.
On the links below, I also included an article about another economic operator which is the European Authorized Representative.
Who is Nicolaj Nitzsch
With over 7 years of experience in the medical device filed where I over the years have developed a strong understanding of the importance of devices and the industry.
I have an education as a Data Technician Specializing in Infrastructure and have a strong mindset for business optimizing in the Nordic market.
I’m passionate about technology in general, Business Development and the industry of Medical and Health Tech because this is something that really can change the quality of life for patients.
- Nicolaj Nitzsch LinkedIn: https://www.linkedin.com/in/nitzsch/
- ScanMed Norway: https://scan-med.com/
- Distributor Roles and Responsibility: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745#d1e2774-1-1
- Easy Medical Device Shop: https://school.easymedicaldevice.com/shop
- Economic Operator: European Authorized Representative: https://easymedicaldevice.com/ec-authorized-representative/