Re: Technical file Own Brand Labelling requirements
This comment would imply that the "true manufacturer" is the company that actually assembles the product.
Per MDD Article I #2(f), "manufacturer" has a specific regulatory meaning:
By this definition, it is incorrect to describe a contract medical-device-maker as a "manufacturer".
Per various MDD-related requirements, including NB-MED/2.5.1/Rec5, the manufacturer is responsible for the technical file.
Perhaps in the first two NB-relationship examples provided above, the NB had concluded that the medical device company was a distributor rather than a manufacturer.
Well, when I say "true manufacturer" I mean "have the whole technical file, as if you were performing all the operations"
The key point is that there is already a manufacturer with CE-marked product, and you are just changing the label. Means that a NB has already assessed the design, manufacture processes etc.
So you need the technical file to show that you have the same characteristics on the label, as his own label, and also a quality agreement showing that the product you will be sent is the same with the one that has been CE-certified originally, and finally i find the risk assessment important.
It is a special case for the NB, where they do not inspect the whole design of the product for example.
I am attaching the British MHRA guidelines.