R
regork
I am a US firm and have a stand-alone software application that transmits and stores medical device data used by hospitals (professionals, non-consumer) that falls outside a medical device classification.
What is required to market in EU? I did not see a directive that would apply that I could CE mark to. Does that mean that I do not have to CE mark? What directive would apply to this product?
Thanks,
Regork.
What is required to market in EU? I did not see a directive that would apply that I could CE mark to. Does that mean that I do not have to CE mark? What directive would apply to this product?
Thanks,
Regork.