Repackaging and translation under MDR

[Billy Milly]

I agree with Junn. Your scenario is describing labelling/packaging and not re-labelling/re-packaging. If you are labelling or packaging, you are the manufacturer in any case. If you re-label (or label additionally, e.g. with your address) and have an agreement with manufacturer, you fall under the exemption.
If you import without "labels and IFU" (unfinished product, not a medical device - you wrote it is not intended for users), you are performing the "last" production step (labelling) and release on the market -> manufacturer.
To re-label or re-pack, you first need to receive a finished, released product (market-ready, compliant, etc) to start with. For example, you receive product pack of 30 with English IFU and e.g. a German hospital requires a 10-pack, you repack and add the translation in order to market the product. The 30-pack is still available on the market.

 

[Stilts]

Cannot we conclude an agreement with the producer (of course if manufacturer agrees to it) in which we are the producer's "subcontractor" and therefore we do not have to take over the role of the legal producer?

 

[Billy Milly]

In general, yes. But this will bring a lot of challenges and costs for the manufacturer (new critical subcontractor - impact on manufacturer's certification, new production site, obligation to audit you, include you into their ISO audit...). If they are ready to take this on them, no problem

 

[Cybel]

I agree with Billy Milly: if you import a device without markings and instructions (so a device that is different from the "original" one - I mean, the one on which the Manufacturer/Authorized Representative has put the CE mark), it seems that you import a semi-finished device and you became a Manufacturer.
But I think that the Chinese Manufacturer/Authorized Representative might:
A) qualify you as critical supplier/subcontractor that repackage the product, but this shall be in some way under their control, it means you have to provide them all the information (i.e. procedures, production reports) and possibly you have to be audited by the Authorized Representative, so that they can issue the Declaration of Conformity having the control of your activity (because as they are manufacturer, they have the complete responsibility of what you do) - all the things that Billy Milly has written in the previous post
and
B) sign an agreement for distribution under your brand (I'm not familiar with class I devices, but for devices for which the intervention of a NB is required, this would be: extend the CE certificate to your brand); the DoC released by the manufacturer (and its Technical Documentation) should make reference to your brand as well.

This is what we do (but in our case there is not importation involved, so it is simpler and because we are in class IIa we are under the control of our NB); your situation is particular, maybe asking for a professional advice may help.

 

[Stilts]

Thank You so much!

Your experience-based advices are so valuable to me.

I don't really have any practical experiance with Medical Devices. I only spent hours reading MDR, discussions in this forum, and listening to the webinars