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.

2 Replies to “Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch”

Charlot Scicluna
November 27, 2019 at 11:35 am

Thank you for this podcast really interesting.

As a side question, since importer was mentioned. The MDR states that the importer is the entity that places a device on the market. By definition, placing a device on the market means the “first making available of a device on the Union Market”
In your opinion does this mean when a device is entered physically to be sold on the EU Market? Or else, let’s say, each time that same device is imported per batch and/or serial number in a specific EU country?

Thanks for your valued input.
- Monir El Azzouzi
  November 27, 2019 at 12:05 pm
  
  Hi Charlot,
  
  I had created a blog post where I give more precision of the term “Placing on the market”. And this is not only for the first batch but for all the following.
  For example if you put on the market some Medical Device compatible with MDD ( Class IIa, IIb, III) but not compatible with MDR, prior to May 26th, 2020 you can still sell them until May 26th 2024
  But from May 26th, 2020 you cannot place them anymore on the market as they are not compliant to MDR.
  Check Article below.
  https://easymedicaldevice.com/mdr-transition/#7

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Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch

Who is Nicolaj Nitzsch

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2 Replies to “Responsibility of a Distributor in MDR & IVDR with Nicolaj Nitzsch”