EU requirements for Hospital Use Health IT software

[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.

 

[Stijloor]

A Quick Bump!

Can someone help?

Thank you very much!!

 

[CharlieUK]

Assuming that it does not meet the definition of a "medical device" as defined in http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:en:PDF

then it's not in scope of the MED
It's also unlikely to be in scope of any other directive, so no CE marking issues to be concerned with.