Distributor obligations under MDR

Udirn1

Starting to get Involved
#1
Dear colloegues,
I was wondering whether you have had the chance to compile and send to your distributors some kind of a plain and simple check list for them to follow in order to comply with the new MDR requirements?
If yes, and you can share, I would appreciate it a a lot.
Thanks
Udi
 
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Cybel

Involved In Discussions
#2
Hi, I'm interested in this topic as well.
I don't know at what step of the process you are, I can share my experience which is limited to the first step, for now: basically I've started sending to my distributors an informative explaining the deadlines related to expiry dates of our MDD certificates and the factsheet prepared by the EU Commission (attached).
But it's time for me to go ahead with more details on this matter, I guess we'll review all our contracts one by one, adding the MDR requirements. A verification that they are respected will follow, of course.
 

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Cybel

Involved In Discussions
#4
Hi, I return to this for sharing a questionnaire for distributors. I would like to use it as preliminary and gap-analysis questionnaire. I think to use answers to check what it is necessary to do with each distributor and how we should modify each QTA.
I share it hoping that it may be helpful as input for discussion on how it is better to proceed.
 

Attachments

nozzle

Involved In Discussions
#5
Do you issue distribution contracts yourself or do your distributors issue their own? Had about a 60% / 40% spilt of being told it's our responsibility vs being sent contracts to review and sign.
 

Cybel

Involved In Discussions
#6
We (manufacturers) have as distributors big companies that make their own contract, so we review, modify something as needed, and sign them.
I don't think it is really important who issues the contract, the important thing is that the contract exists, is carefully checked by both parties, signed and kept up to date.
 
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