Hi All,

I would appreciate your thoughts on the following scenario:

 

Company A designs a medical product that incorporates a wireless device,
let’s say, a wireless PCI card. The wireless card is manufactured by Company
B and has been evaluated to the R&TTE directive and thus CE-marked. This
wireless card is installed in the end medical product, unmodified and
according to manufacturer’s instructions.

 

Company A’s name goes onto the end product, but Company B’s name,
markings, labeling etc. remain on the wireless card. Would Company A need to
consider R&TTE (in addition to the MDD) for their end product? If yes, what
additional testing would this encompass? 

 

Thanks!

Del


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