In my opinion a SW product can be a medical device itself only if it falls
in the scope of the MDD (Art. 1 ยง2): diagnosis, prevention, monitoring,
treatment or alleviation of disease/injury/handicap. For example if your SW
is intended to process and interprete clinical data, it is a medical
device. On the contrary if it is intended only to archive clinical data it
is not a medical device.
About the CE marking I think that if you sell the SW to be used in any PC,
processing data from any other medical device, you must follow a conformity
assessment procedure and affix the CE mark. On the other hand, if your SW
runs only as an accessory of one of your CE marked medical devices, you
shall include it in your technical files and manage to have the whole
product in conformity with the MDD essential requirements.
As a standard reference you can follow requirements of EN60601-1-4 that is
applicabile to Programmable Electronic Medical Devices.
Hopefully, it can help.
Massimo
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ESAOTE S.p.A. Massimo Polignano
Research & Product Development Regulatory Affairs
Via di Caciolle,15 tel:+39.55.4229402
I- 50127 Florence fax:+39.55.4223305
e-mail: [email protected]
