ISO 13485 and OBL (Own Brand Label) Agreement

Ronen E

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#21
I really appreciate your feedback. The reason I said that different NB requires different thing is because I have read that on this forum. For example, some of them will waive the audition of the OEM and accept OEM certification and others do not. so this tell me that every NB has different requirements..
Again: You have taken the statement regarding difference between NBs (which I have also made) out of context, and might be reaching wrong conclusions / decisions based on that.

In this specific case there are 2 options (assuming that the OEM already have their device cleared for CE marking by a NB):

1. Engaging with the same NB that cleared the device for the OEM. In this case the NB is likely to not audit the OEM an additional time, just because you are applying as an OBL. They will continue to audit the OEM for their own clearance (which will also be the basis for your clearance), based on their original schedule. Whether or not they will audit you (the OBL) is a separate question that depends on many factors. Based on Danny's post it seems likely that in the current atmosphere they will.

2. Engaging with any NB that is not the one that cleared the device for the OEM. In that case there will be little/no OBL/OEM concessions. You will certainly be audited as the responsible (legal) manufacturer, and the OEM is likely to be audited too, on top of them being audited by their original NB (they will in total be audited by at least 2 NBs). The fact that the OEM already has clearance for CE marking (by a different NB) will not play a major role in the auditing / certification process, though the same documentation and evidence such as ISO 13485 certificate already obtained by the OEM will most certainly assist.

Cheers,
Ronen.
 
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