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
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