Question on ISO 13485 & MDR
The reason of my interest is not that that I want or must have the ISO13485 certification, but my supplier (a medical device manufacturer) for whom I sell their devices already for over 10 years, is suddenly asking me a list of all my clients, as they say they must contact my clients in view of ISO13485 & MDR…?
In my belief, this is not compulsory for them to do.
Are you in agreement with me?
As their rep. and sales office I can contact of course my buyers on their behalf, IF at all needed??
Assign topic to the user
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
In MDR in article 14 there are stated General obligations of distributors. Distributor need to inform manufacturer in the following situations:
Therefore, you are not obliged to provide to manufacturers all your client list.
Dear Kristina,
Many thanks for your reply, which confirms exactly what I already expected it to be. Unfortunately my supplier "tries" to collect my list of clients in order to get in touch with them directly. Simply because their sales are decreasing worldwide, which can be explained of course, as I have my experience with them for over 10 years. Guidelines have changed in the medical world and in our case not to the benefits of the supplier/manufacturer. And therefore they think they can contact clients better directly...... Imagine. Now they used the argument that I "must" supply them the list of clients because ISO 13485 "demands" this....
Once more many thanks your cler answers.
Best regardds,
René van Liemt
www.arteriograph.nl
Comment as guest or Sign in
Apr 17, 2020