Mobile Medical Device for MDD - Medical Image Viewer

Hello all
I am having trouble finding any guidance documents for MDD around the subject of Mobile Device.
Our Medical Image Viewer is classified along with PACS as class I.

Is we want to use for mobile does this make it Class IIa or change the classification at all?

The FDA came out with a guidance and Health Canada has some regulations around this...does MDD?

Thank you in advance for some insight.

A Quick Bump!

Can someone help?

Thank you very much!!

Hello cmeby,

There's nothing about mobile medical devices in the MDD and in the guidances, so far.
An english non profit organization issued a white paper about health apps: http://blog.d4.org.uk/2012/01/regulation-of-health-apps-a-practical-guide.html
I think this is the most recent state of the art in EU but it is abolutely not official.
Otherwise you can rely on FDA draft guidance on mobile medical apps.

IMHO, the class doesn't change with the fixed/mobile criteria. You only add technical risks of connection loss, cyber threats but you don't change the intended use.

Regards,
Mitch.