Distribution of a Class 3 Medical Device

Dave-h

Involved In Discussions
For one particular class 3 device, we are considering changing it from a "Virtual Manufacturer" (own-branded) device, to a "Distribution" device.

Does anyone know what an EU Notified Bodies stance would be for Class 3 distributed products?

Thanks,
 

pkost

Trusted Information Resource
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.
 

Ronen E

Problem Solver
Moderator
For one particular class 3 device, we are considering changing it from a "Virtual Manufacturer" (own-branded) device, to a "Distribution" device.

Does anyone know what an EU Notified Bodies stance would be for Class 3 distributed products?

Thanks,

Most of your EU regulatory responsibilities will revert to the OEM (who will now be the Manufacturer of record).

Under the up and coming MDR distributors will have more responsibilities.
 

Dave-h

Involved In Discussions
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.

Thanks
 

pkost

Trusted Information Resource
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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