I assume you mean you are going to declare the OEM as manufacturer on pack?
will your branding appear on pack?
It is acceptable to use the OEM as manufacturer and their branding - this is a normal distribution model. Where things become more complex is if you include your branding. It is not prohibited, but it must remain clear that the OEM is the manufacturer.
The new MDR (which does not apply just yet) does cover using an OEM as manufacturer with your branding - it is not permitted unless there is a technical agreement in place identifying responsibilities.
It would be a simple distribution model, with none of our branding. It would be as supplied by the oem.
I'd be interested to know if a Notified Body would be interested because it's class 3. I know they are not particularly interested in class 1 or 2a distributed products.
notified bodies provide oversight of the design and manufacture process to ensure the product is safe and effective. i.e. up until release.
They have little interest in what happens downstream except for the reporting of complaints back up to the manufacturer to ensure PMS obligations are met.
If you retain an NB for any other products that you manufacture or 13485, the product you refer to will be out of scope of any MDD assessment, but will be in scope of your ISO certification
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