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Would anyone have any upto date information documents on the role of distributors in UK MDD/ MDR. With the changes of the MHRA now extending the deadline also, some of my customers and sub distributors are asking me questions that I don't have answers to, becasue as far as I was aware I can't see any changes that imapct distributors.
I'd like to know if we need, for the certification puroposes, a filled device classification map (questionnaire) or if the result of classification is enough? In order words, is the chosen MD class enough or we need to show how we got to the specific MDR/IVDR class?
To clarify bit more: we used an online software to classify the MD. We got the result, but not the path with questions and answers.
“Is our MDR compliant Software as MedDev (SaMD) CFR compliant in USA?”
Gap analysis MDR vs CFR 21