Can we put two Manufacturer's address in IFU (Instructions For Use)?

sreenu927

Quite Involved in Discussions
#1
Hi All,

Company A has a medical device product 'a' (assay) obtained CE marking.
Company B has a medical device product 'b' (instrument) also obtained CE marking.
Now both products were used for clinical studies as a system 'c', which will be sold to US market.

1. In the (common or single)User manual, can we have both manufacturers'(A&B) name and address?
Note: For device labels, it is separate.

2. Do we need to notify to the Notified Body in EU for this change for product 'a'(assay), that has NB intervention?

Thanks,
Sreenu
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi All,

Company A has a medical device product 'a' (assay) obtained CE marking.
Company B has a medical device product 'b' (instrument) also obtained CE marking.
Now both products were used for clinical studies as a system 'c', which will be sold to US market.

1. In the (common or single)User manual, can we have both manufacturers'(A&B) name and address?
Note: For device labels, it is separate.

2. Do we need to notify to the Notified Body in EU for this change for product 'a'(assay), that has NB intervention?

Thanks,
Sreenu
Hi,

As far as I understood, question #1 relates to USA regulation. Is that correct? If so, in my opinion you have to specify the name and address of the system ("c") legal manufacturer (regulatorily responsible entity). If you wish to add details regarding companies "A" and "B", I think you should be able to do that, as long as it doesn't in any way obscure who is the regulatorily responsible entity.

Regarding your other question, I couldn't figure out what change you were referring to.

Cheers,
Ronen.
 

sreenu927

Quite Involved in Discussions
#3
Hi Ronen,

Thanks for your quick reply. Yes. Both instrument and assay bear CE marking.
Now as a system, wud like to distribute in US market. As there will be 2 FDA submissions(1 for instrument and 1 for assay), so there is no legally responsible for whole system. It's based on agreement b/w both the parties.
So in the user manual, we provide information of both instrument and assay. To provide the details of manufacturer, is that acceptable by FDA to include both companies?

reg Q#2, as 'a' has NB intervention, now we are using 'a' with 'b' to register in US, do we need to inform NB or not?

Thanks,
Sreenu
 
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