There are plenty of threads regarding OBL but to skim over it and highlight the most important point here: for your customer to say that they are the manufacturer, they must obtain a CE mark. This is easier in OBL because one NB cannot contradict another therefore the OBL states that the device is identical and the new NB should automatically grant their approval with minimal review. That being said the OBL still requires a QMS and technical file, although large parts can refer to the original manufacturers.
Additionally, what hasn't been considered here is, what if there is a problem with the device? as the manufacturer you will be responsible for reporting it and carrying out CAPA; what if your customer doesn't like your actions? It will sour the relationship somewhat.
From the limited information you have posted here, I would think that you acting as their EC-rep may be a good idea. Hand them the file and get them to obtain 13485 (it sounds like they will need it anyway).
Additionally, what hasn't been considered here is, what if there is a problem with the device? as the manufacturer you will be responsible for reporting it and carrying out CAPA; what if your customer doesn't like your actions? It will sour the relationship somewhat.
From the limited information you have posted here, I would think that you acting as their EC-rep may be a good idea. Hand them the file and get them to obtain 13485 (it sounds like they will need it anyway).
