Oversight of Distributors - Supply chain requirements under the MDR

tebusse

Involved In Discussions
#1
Greetings,

I've been reviewing the supply chain requirements under the MDR and have a question or two for the group.

Are we required to have oversight of our distributors outside of our Quality Agreement in order to comply with the MDR? Meaning, are we required to list distributors on the Approved Supplier List and qualify them as a supplier?

Since the distributor is defined as being part of the supply chain and that they have specific requirements within the regulation that must be met, I'm inclined to interpret the regulation that we treat them as we would any supplier.

Thank you, Tonia
 
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#2
Without any other background knowledge, I would agree with your conclusion.
I interpret the supplier evaluation and selection process as broadly applicable for all suppliers, with a focus on establishing criteria based on risk, performance, etc.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I wouldn’t read into the MDR more than it actually spells out (or what’s in any official interpretation/guidance). There are fairly explicit and elaborate requirements for distributors - you need to comply with these and that’s it.

You need to distinguish agents from distributors.

Distributors actually BUY devices from you and on-sell. So they are customers (though not users) and not suppliers.

Agents don’t take title of the devices. They might physically hold them, but they don’t own them. So they only provide a service - furthering the distribution of the devices - and thus they would be suppliers. In that case all the requirements that apply to suppliers would apply to them.

Normally when discussing your “supply chain” it relates more to up-stream (all the way from raw materials to you) than to down-stream (from you to the end-user).
 

Mark Meer

Trusted Information Resource
#5
...Distributors actually BUY devices from you and on-sell. So they are customers (though not users) and not suppliers...
I agree with this in principle, but in the context of our quality system it makes sense to treat distributors as suppliers.
(as an aside, I believe this is actually a requirement for Health Canada in the MDSAP audit model).

In practice, they can be treated as both supplier and customer: supplier with respect to sourcing, qualification, and monitoring; customer with respect to orders and feedback.
 

Edward Reesor

Trusted Information Resource
#6
For our MDSAP audit (by the same company who used to audit us for MDR), we were asked to treat our distributors like critical suppliers, and even wanted us to have signed statements from them stating that they would conform to the standards (even though they are themselves registered as medical device distributors by Health Canada).

It seems like a redundant exercise that serves no purpose as they have their own certification process and/or could just as easily sign the paper and be done with it.
 
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