CE requirement for software importer / reseller - Class II for FDA and Health Canada

[MtlGuy]

Hi All,

I looked through the other posts but did not find one that quite answered a question I had.

Our company (based in Canada) develops medical imaging software, a class IIa device (as far as CE is concerned, class II for FDA and Health Canada). We also distribute / resell other computer software which is either class I or II as far as CE is concerned in order to round out our product offering.

We do not manufacture or put our name on the 3rd party software that we distribute. The software can be purchased directly from the manufacturer, but we also offer the option of purchasing it through us. If purchased through us, we will do the installation and support for the software.

My questions are: if the software the we distribute (but do not manufacture) does not have CE marking, are we legally able to sell / distribute it into Europe? Is it the manufacturer who is responsible for getting the CE mark, or would we, as a distributor, be able to apply for them?

While we're at it, how does the same rule apply to FDA in the US and Health Canada in Canada? (Meaning if the software has not been FDA approved, can we sell it in the US, and if not, who is responsible for getting FDA approval, the manufacturer or the distributor?). Ditto for Canada.

Thanks for the help.

MtlGuy

[DannyK]

It all depends if the software is considered a medical device. It may be best this question to a notified body.

Danny