In Reply to Parent Post by ehoqa
Suppose the only contact information that shows up on the product is the distributor's. Is the issue of relaying complaints/ reportable events to us addressed in a contract?
Yes, and with mutual procedures. I suggest that you agree with the Distributor that your quality team will periodically audit them for their compliance with aspects of the contract that affect your regulatory compliance. The Manufacturer is solely and fully responsible for MDR, however the product is labeled.